Organ donation for transplantation: improving donor identification and consent rates for deceased organ donation

NICE clinical guideline 135

Guideline appendices

Contents Appendix A Scope ...... 2 Appendix B How this guideline was developed ...... 9 Appendix C References of all included studies ...... 60 Appendix D Full GRADE evidence profiles ...... 69 Appendix E Evidence tables ...... 94

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Appendix A Scope

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE 1 Guideline title

Organ donation for transplantation: improving donor identification and consent rates for deceased organ donation

1.1 Short title

Organ donation for transplantation

2 The remit

The Department of Health has asked NICE: ‘To produce a clinical guideline on improving donor identification and consent rates for cadaveric organ donation’.

Terms used in this scope Brain-stem death Death diagnosed after irreversible cessation of brain stem function and confirmed using neurological criteria. The diagnosis of death is made while the body of the person is attached to an artificial ventilator and the heart is still beating. Cardiac death Death diagnosed and confirmed by a doctor after cardiorespiratory arrest. Potential donors People for whom brain-stem death or cardiac death has been diagnosed and active treatment is planned to be withdrawn, and who have no medical contraindications to solid organ donation. See Department of Health (2008) Organs for transplants: a report from the Organ Donation Taskforce. Available from www.dh.gov.uk/en/Publicationsandstatistics/Publications

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3 Clinical need for the guideline

3.1 Epidemiology a) Organ transplantation has a major role in the management of patients with failure of a single organ system of either the kidneys, small bowel, liver, pancreas, heart, lung, or thymus, and of combined organ failure of the heart and lung, the kidney and pancreas, the liver and kidney, or liver and small bowel. Transplants may be needed because of primary organ disease, such as chronic inflammatory disease of the kidneys or cardiomyopathy, or because of secondary effects such as kidney, islet cell and pancreas transplants in people with diabetes, and lung transplants in people with cystic fibrosis. b) The distribution of the population on the transplant waiting list is 75% white, 25% non-white; 59% male, 41% female; 7% aged 0–17 years, 18% aged 18–34 years, 39% aged 35–49 years, 20% aged 50–59 years, 15% aged 60+ years. c) There is a shortage of organs for transplant resulting in long waits for transplantation and a significant number of deaths while awaiting transplantation. d) Approximately 8,000 people in the UK are waiting for an organ transplant. This figure is rising by about 5% per year because of a number of factors, such as: increasing prevalence of renal and liver disease; ethnic diversity of the UK population; lower thresholds for transplantation and better clinical management of serious illnesses. The true need is likely to be greater and is rising rapidly with changing demographics of the UK. Of particular note are an ageing population and an anticipated increase in the incidence of type 2 diabetes, a condition that can cause kidney failure and lead to the need for a kidney transplant.

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e) At any one time, a significant number of patients may be suspended from the active list. This is because their condition has temporarily deteriorated to the extent that a transplant is too risky. In 2008–09, 2552 transplants used organs from deceased donors; however, another 1178 patients were listed for transplant, of whom 448 died before receiving one and 730 were removed from the list. f) Data from NHS Blood and Transplant, on transplant activity in the UK 2008–09, showed that only 86% of potential donors after brain- stem death, and 42% of potential donors after cardiac death, were referred to donor coordinators. Of those families approached, permission was refused for donation to proceed for 38% of possible DBD (donation after brain-stem death) donors, and 42% of possible DCD (donation after cardiac death) donors

3.2 Current practice a) Europe has an average of 17.8 donors per million people. The UK has one of the lower rates at 15.5 donors per million people. b) Clinical practice, and whether families are asked to consider organ donation, varies significantly across the UK. The conversion rates for potential donors becoming actual donors in 2008/ 09 varied between 23.7% and 43%. In 2008–09, the mean conversion rate in UK intensive care units for potential donors becoming actual donors was about 51% for DBD to 15% for DCD. c) Kidney transplantation is more cost-effective than haemodialysis for treating stage 5 chronic kidney disease, but it is less commonly used than it should be due to shortage of transplantable kidneys. An increase in transplant rates will have a beneficial impact on resources and will increase quality of life for patients that are suitable for transplantation and are currently on dialysis. d) NHS Blood and Transplant data show that only 5% of deceased donors are of Asian or African–Caribbean descent, even though

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these groups form 25% of the kidney transplant waiting list. People of Asian or African–Caribbean descent are three to four times more likely than white people to develop end-stage renal failure and to need a kidney transplant. People from these populations are also much less likely to give consent for organ donation when asked. e) A UK transplant1 survey in 2003 showed that the public is very supportive of organ donation in principle, with 90% in favour. Nearly 17 million people are already on the NHS Organ Donor Register. However, the actual donation rate in the UK remains poor. This may be partly because of bereaved relatives not consenting to organ donation. Many reviews of organ donation have been done in the past, but all failed to resolve the problems that result from the lack of a structured and systematic approach to organ donation. f) The guideline will focus on identifying potential donors and obtaining consent for solid organ donation under current legislation. It will help to address the burden of disease by increasing the availability of organs for transplant. It will address current inequalities by helping to make organ donation a usual part of NHS practice, meaning that families of all potential organ donors are approached and supported, irrespective of factors such as ethnicity and religion.

4 The guideline

The guideline development process is described in detail on the NICE website (see section 6, ‘Further information’).

This scope defines what the guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health.

The areas that will be addressed by the guideline are described in the following sections.

1 In 2003, UK transplant subsequently changed to NHS Blood and Transplant. Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 5 of 202

4.1 Population

4.1.1 Groups that will be covered a) Families, relatives and legal guardians of potential DBD donors (adults and children). b) Families, relatives and legal guardians of potential DCD donors (adults and children). c) Within this population, the following groups have been identified as needing special consideration:

people from black and minority ethnic groups. people with differing religious beliefs.

4.1.2 Groups that will not be covered a) Groups involved in giving consent on organ donation other than those described in sections 4.1.1a and 4.1.1b.

4.2 Healthcare setting a) NHS hospitals.

4.3 Clinical management

4.3.1 Key clinical issues that will be covered

Structures and processes for identifying potential DBD and DCD donors

timing of referral criteria for consideration

Structures and processes for obtaining consent for deceased organ donation for transplantation, including the optimum timing for approaching families about consent.

Coordination of the care pathway from identification of potential donors to consent. Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 6 of 202

Competencies of healthcare professionals involved in the activities described in sections 4.3.1 a, b and c.

4.3.2 Clinical issues that will not be covered a) Systems for declaring a willingness to donate before death. b) Tissue donation. c) The processes of organ retrieval. d) Living organ donation. e) Assessment of organs for transplantation. f) Organ donation for training and medical research. g) Prioritisation of organ allocation, including the structures and processes of organ transfers within or outside the UK.

4.4 Main outcomes a) Rates of identification of potential donors. b) Rates of consent for donation. c) Rates of organ donation for transplantation d) Rates of successful transplants. e) Rates of viable organs retrieved. f) Rates of family, relatives and legal guardians’ refusal. g) Families, relatives and legal guardians' experience of the structures and processes for organ donation.

4.5 Economic aspects

It is unlikely that standard HE modelling techniques will apply to this guideline. In the absence of these a cost impact analysis will be under taken that looks

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at how identification and consent impacts on current resources. The cost impact analysis will be included in the main text of the guideline.

4.6 Status

4.6.1 Scope

This is the final scope.

4.6.2 Timing

The development of the guideline recommendations will begin in September 2010.

5 Related NICE guidance

There is no related NICE guidance for this topic.

6 Further information

Information on the guideline development process is provided in:

‘How NICE clinical guidelines are developed: an overview for stakeholders the public and the NHS’ ‘The guidelines manual’.

These are available from the NICE website (www.nice.org.uk/GuidelinesManual). Information on the progress of the guideline will also be available from the NICE website (www.nice.org.uk).

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Appendix A How this guideline was developed

This guideline was developed in accordance with the process for short clinical guidelines set out in ‘The guidelines manual' (2009) (see www.nice.org.uk/GuidelinesManual). There is more information about how NICE clinical guidelines are developed on the NICE website (www.nice.org.uk/HowWeWork). A booklet, ‘How NICE clinical guidelines are developed: an overview for stakeholders, the public and the NHS’ (fourth edition, published 2009), is available from NICE publications (phone 0845 003 7783 or email [email protected] and quote reference N1739).

Search strategies Medline search strategies for the Organ Donation guideline

Scoping searches Scoping searches were undertaken in March 2010 using the following websites and databases (listed in alphabetical order); browsing or simple search strategies were employed. The search results were used to provide information for scope development and project planning.

Guidance/guidelines Systematic reviews/economic evaluations

British Medical Association Clinical Evidence Canadian Medical Association Infobase Cochrane Database of Systematic Clinical Knowledge Summaries Reviews (CDSR) Department of Health Database of Abstracts of Reviews of Effects (DARE) Donor Family Network Health Economic Evaluations Database European Transplant Coordinators (HEED) Organisation Health Technology Assessment (HTA) General Medical Council Database Guidelines International Network (GIN) NHS Economic Evaluation Database Human Tissue Authority (NHS EED) National Guideline Clearing House (US) NHS R&D Service Delivery and National Health and Medical Research Organisation (NHS SDO) Programme Council (Australia) National Institute for Health Research National Institute for Health and Clinical (NIHR) Health Technology Assessment Excellence (NICE) – guidance published Programme & in development TRIP Database National Institute for Health and Clinical Excellence (NICE) – topic selection

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NHS Blood and Transplant NHS Confederation NHS Evidence New Zealand Guidelines Group Royal College of General Practitioners Royal College of Pathologists Scottish Intercollegiate Guidelines Network (SIGN)

Main searches The following sources were searched for the topics presented in the sections below.

• Cochrane Database of Systematic Reviews – CDSR (Wiley) • Cochrane Central Register of Controlled Trials – CENTRAL (Wiley) • Database of Abstracts of Reviews of Effects – DARE (CRD) • Health Technology Assessment Database – HTA (CRD) • CINAHL (NHS Evidence) • EMBASE (Ovid) • MEDLINE (Ovid) • MEDLINE In-Process (Ovid)

The MEDLINE search strategies are presented below. They were translated for use in all of the other databases.

Search for identification of potential organ donors

1 exp Death, Sudden/

2 Brain death/

3 (("brain stem" or brainstem or brain-stem or brain or neuro* or medulla*) adj3 (death* or dead or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

4 ((cardiac or heart or cardio*) adj3 (death* or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

5 (post mortem* or cadaver* or dead or death* or deceased).ti,ab.

6 or/1-5

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7 exp "Tissue and organ procurement"/ or Tissue donors/

8 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab.

9 7 or 8

10 Decision Making/

11 (identif* or select* or confirm* or establish* or ascertain* or verif* or distinguish* or classif* or recogniz* or recognis* or determin* or deci* or qualif* or refer* or recruit* or initiat* or criteri* or accept* or potential* or attitud* or characteris* or find* or discover* or verif* or diagnos*).ti.

12 10 or 11

13 6 and 9 and 12

14 animals/ not humans/

15 13 not 14

16 limit 15 to english language

Search for clinical triggers for referral to organ donation team

1 exp "Tissue and organ procurement"/ or Tissue donors/ 2 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab. 3 1 or 2 4 trigger*.tw. 5 "Referral and Consultation"/ 6 Models, Organizational/ 7 ("task force" or "taskforce" or "task-force").ti,ab. 8 or/4-7 9 3 and 8 10 animals/ not humans/ 11 9 not 10 12 limit 11 to english language

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1 exp Death, Sudden/

2 Brain death/

3 (("brain stem" or brainstem or brain-stem or brain or neuro* or medulla*) adj3 (death* or dead or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

4 ((cardiac or heart or cardio*) adj3 (death* or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

5 (postmortem or post-mortem or post mortem* or cadaver* or dead or death* or deceased).ti,ab.

6 or/1-5

7 exp "Tissue and organ procurement"/ or Tissue donors/

8 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab.

9 7 or 8

10 exp Informed Consent/ or exp Third-Party Consent/ or exp Consent Forms/ or exp Presumed Consent/ or exp Parental Consent/

11 (consent* or agree* or accept* or allow* or permi* or sanction* or approv* or cooperat* or co-operat* or compl* or obtain* or assent* or authoris* or authoriz* or concur* or accede* or endors*).ti.

12 10 or 11

13 6 and 9 and 12

14 animals/ not humans/

15 13 not 14

16 limit 15 to english language

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Search for timing of approach

1 exp Death, Sudden/

2 Brain death/

3 (("brain stem" or brainstem or brain-stem or brain or neuro* or medulla*) adj3 (death* or dead or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

4 ((cardiac or heart or cardio*) adj3 (death* or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

5 (postmortem or post-mortem or post mortem* or cadaver* or dead or death* or deceased).ti,ab.

6 or/1-5

7 exp "Tissue and organ procurement"/ or Tissue donors/

8 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab.

9 7 or 8

10 Time/ or Time Factors/ or Time Management/

11 (time* or timing*).tw.

12 10 or 11

13 exp Informed Consent/ or exp Third-Party Consent/ or exp Consent Forms/ or exp Presumed Consent/ or exp Parental Consent/

14 (consent* or agree* or accept* or allow* or permi* or sanction* or approv* or cooperat* or co-operat* or compl* or obtain* or assent* or authoris* or authoriz* or concur* or accede* or endors*).ti.

15 13 or 14

16 6 and 9 and 12 and 15

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17 Animals/ not Humans/

18 16 not 17

19 limit 18 to english language

Search for care pathways in organ donation

1 exp Death, Sudden/

2 Brain death/

3 (("brain stem" or brainstem or brain-stem or brain or neuro* or medulla*) adj3 (death* or dead or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

4 ((cardiac or heart or cardio*) adj3 (death* or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

5 (postmortem or post-mortem or post mortem* or cadaver* or dead or death* or deceased).ti,ab.

6 or/1-5

7 exp "Tissue and organ procurement"/ or Tissue donors/

8 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab.

9 7 or 8

10 Critical pathways/

11 "Delivery of Health Care, Integrated"/

12 Patient care planning/

13 ((care or clinical or integrated or multidisciplinary or critical) adj3 (pathway* or path* or plan* or protocol* or procedure* or program* or

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programme* or manag* or process* or outline* or algorithm* or map* or schedul*)).ti,ab.

14 or/10-13

15 6 and 9 and 14

16 animals/ not humans/

17 15 not 16

Search for competencies of staff in organ donation

1 exp "Tissue and organ procurement"/ or Tissue donors/

2 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab.

3 1 or 2

4 Inservice Training/

5 exp Professional Competence/

6 (competenc* or skill* or train* or abilit* or expert* or role* or capab* or capacit* or technique* or know*).ti,ab.

7 or/4-6

8 (coordinator* or co-ordinator* or "co ordinator").ti,ab.

9 exp Nurses/

10 nurse.ti,ab.

11 exp Medical Staff/

12 (doctor* or consultant* or physician* or surgeon* or attending or clinician*).ti,ab.

13 ((critical or intensive or medical) adj3 (staff or personnel or care)).ti,ab.

14 or/8-13 Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 15 of 202

15 3 and 7 and 14

16 animals/ not humans/

17 15 not 16

18 limit 17 to english language

Search for economic studies

1 exp Death, Sudden/

2 Brain death/

3 (("brain stem" or brainstem or brain-stem or brain or neuro* or medulla*) adj3 (death* or dead or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

4 ((cardiac or heart or cardio*) adj3 (death* or injur* or sever* or irreversib* or damage* or traum* or fail* or arrest*)).ti,ab.

5 (postmortem or post-mortem or post mortem* or cadaver* or dead or death* or deceased).ti,ab.

6 or/1-5

7 exp "Tissue and organ procurement"/ or Tissue donors/

8 ((don* or procur*) adj3 (tissue* or organ*)).ti,ab.

9 7 or 8

10 Economics/ use mesz

11 exp "Costs and Cost Analysis"/

12 Economics, Dental/

13 exp Economics, Hospital/

14 exp Economics, Medical/

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15 Economics, Nursing/

16 Economics, Pharmaceutical/

17 Budgets/

18 exp Models, Economic/

19 Markov Chains/

20 Monte Carlo Method/

21 Decision Trees/

22 econom$.tw.

23 cba.tw.

24 cea.tw.

25 cua.tw.

26 markov$.tw.

27 (monte adj carlo).tw.

28 (decision adj2 (tree$ or analys$)).tw.

29 (cost or costs or costing$ or costly or costed).tw.

30 (price$ or pricing$).tw.

31 budget$.tw.

32 expenditure$.tw.

33 (value adj2 (money or monetary)).tw.

34 (pharmacoeconomic$ or (pharmaco adj economic$)).tw.

35 or/10-34

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36 "Quality of Life"/ use mesz

37 quality of life.tw.

38 "Value of Life"/ use mesz

39 Quality-Adjusted Life Years/ use mesz

40 quality adjusted life.tw.

41 (qaly$ or qald$ or qale$ or qtime$).tw.

42 disability adjusted life.tw.

43 daly$.tw.

44 Health Status Indicators/ use mesz

45 (sf36 or sf 36 or short form 36 or shortform 36 or sf thirtysix or sf thirty six or shortform thirtysix or shortform thirty six or short form thirtysix or short form thirty six).tw.

46 (sf6 or sf 6 or short form 6 or shortform 6 or sf six or sfsix or shortform six or short form six).tw.

47 (sf12 or sf 12 or short form 12 or shortform 12 or sf twelve or sftwelve or shortform twelve or short form twelve).tw.

48 (sf16 or sf 16 or short form 16 or shortform 16 or sf sixteen or sfsixteen or shortform sixteen or short form sixteen).tw.

49 (sf20 or sf 20 or short form 20 or shortform 20 or sf twenty or sftwenty or shortform twenty or short form twenty).tw.

50 (euroqol or euro qol or eq5d or eq 5d).tw.

51 (qol or hql or hqol or hrqol).tw.

52 (hye or hyes).tw.

53 health$ year$ equivalent$.tw. Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 18 of 202

54 utilit$.tw.

55 (hui or hui1 or hui2 or hui3).tw.

56 disutili$.tw.

57 rosser.tw.

58 quality of wellbeing.tw.

59 quality of well-being.tw.

60 qwb.tw.

61 willingness to pay.tw.

62 standard gamble$.tw.

63 time trade off.tw.

64 time tradeoff.tw.

65 tto.tw.

66 or/36-65

67 35 or 66

68 6 and 9 and 67

69 animals/ not humans/

70 68 not 69

71 limit 70 to english language

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Review protocols and clinical questions Key clinical issues and review questions Key clinical Issues Review questions Structures and processes including timing for referral Review question 1: and criteria for consideration for identifying potential DBD What structures and processes including timing for referral and criteria for consideration are and DCD donors appropriate and effective for identifying potential DBD and DCD donors? Structures and processes for obtaining consent for cadaveric organ donation for transplantation, including Review question 2: the optimum timing for approaching the families about What structures and processes are appropriate and effective for obtaining consent from consent. families, relatives and legal guardians of potential DBD and DCD donors? Coordination of the care pathway for conversion of potential donors to actual donors. Review question 3: Competencies of healthcare professionals involved in the When is the optimal time for approaching the families, relatives and legal guardians of activities described above. potential DBD and DCD donors for consent?

Review question 4: How the care pathway of deceased organ donation should be coordinated to improve potential donors giving consent?

Review question 5: What key skills and competencies are important for healthcare professionals to improve the structures and processes for identifying potential DBD and DCD; to improve structures and processes for obtaining consent; and to effectively coordinate the care pathway from identification to obtaining consent?

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Review protocols Details Notes & Status 1. Review question 1 What structures and processes including timing for referral and criteria for consideration are appropriate and effective for identifying potential DBD and DCD? 2. Objectives To identify all relevant literature on structures and processes including timing for referral and criteria for consideration for identifying potential DBD and DCD donors. 3. Language English only 4. Study design No restrictions. 5. Status Published papers (full papers only) 6. Population & Inclusion: Healthcare setting Families, relatives and legal guardians of potential DBD and DCD donors (adults and children). • Subgroups considerations: (i) people from black and minority ethnic groups; (ii) people with differing religious beliefs. Healthcare professionals.

Setting: Hospitals. 7. Intervention Appropriate and effective structures and processes including timing for referral and criteria for consideration for identifying potential DBD and DCD donors. 8. Comparisons N/A 9. Outcomes Rates of identification of potential donors. Rates of consent for donation. Rates of organ donation for transplantation (donors per million population per year). Rates of conversion for potential donors with consent to actual donors. Rates of successful transplants. Rates of viable organs retrieved. Rates of family, relatives and legal guardians’ refusal. Families, relatives and legal guardians' experience of the structures and processes for organ donation. 10. Other criteria for Exclusion: inclusion/ exclusion The structures and process for identifying potential of studies DBD and DCD donors for single organs. Systems for declaring a willingness to donate ante- mortem. Tissue donation The processes of organ retrieval. The structures and process of living organ donation. Assessment of organs for transplantation. Organ donation for training and medical research. Prioritisation of organ allocation, including the structures and processes of organ transfers within or outside the UK. 11. Search strategies Please see appendix B. 12. Review strategies Appropriate NICE Methodology Checklists, depending on study designs, will be used as a guide to appraise the quality of individual studies.

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Data on all included studies will be extracted into evidence tables. Where statistically possible, a meta-analytic approach will be used to give an overall summary effect. All key outcomes from evidence will be presented in GRADE profiles, or modified evidence profiles depending on the study design, and further summarised in evidence statements.

Details Notes & Status 1. Review question 2 What structures and processes are appropriate and effective for obtaining consent from families, relatives and legal guardians of potential DBD and DCD donors? 2. Objectives To identify all relevant literature on structures and processes for obtaining consent for deceased organ donation for transplantation. 3. Language English only. 4. Study design No restrictions. 5. Status Published papers (full papers only) 6. Population & Inclusion: Healthcare setting Families, relatives and legal guardians of potential DBD and DCD donors (adults and children). • Subgroups considerations: (i) people from black and minority ethnic groups; (ii) people with different religious beliefs. Setting: Hospitals. 7. Intervention Structures and processes for obtaining consent from families, relatives and legal guardians of potential DBD and DCD donors. 8. Comparisons N/A 9. Outcomes Rates of identification of potential donors. Rates of consent for donation. Rates of organ donation for transplantation (donors per million population per year). Rates of conversion for potential donors with consent to actual donors. Rates of successful transplants. Rates of viable organs retrieved. Rates of family, relatives and legal guardians’ refusal. Families, relatives and legal guardians' experience of the structures and processes for organ donation. 10. Other criteria for Exclusion: inclusion/ exclusion The structures and process for obtaining consent of studies from families, relatives and legal guardians of potential DBD and DCD donors for single organs. Groups involved in giving consent on organ donation other than population specified above. Systems for declaring a willingness to donate ante- mortem. Tissue donation The processes of organ retrieval. The structures and process of living organ donation. Assessment of organs for transplantation. Organ donation for training and medical research. Prioritisation of organ allocation, including the

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structures and processes of organ transfers within or outside the UK. 11. Search strategies Please see appendix B. 12. Review strategies Data on all included studies will be extracted into evidence tables. Where statistically possible, a meta-analytic approach will be used to give an overall summary effect. All key outcomes from evidence will be presented in GRADE profiles, or modified evidence profiles depending on the study design, and further summarised in evidence statements.

Details Notes & Status 1. Review question 3 When is the optimal time for approaching the families, relatives and legal guardians of potential DBD and DCD donors for consent? 2. Objectives To identify all relevant literature on optimum timing for approaching the families about consent. 3. Language English only 4. Study design No restrictions. 5. Status Published papers (full papers only) 6. Population & Inclusion: Healthcare setting Families, relatives and legal guardians of potential DBD and DCD donors (adults and children). • Subgroups considerations: (i) people from black and minority ethnic groups; (ii) people with different religious beliefs. Setting: Hospitals. 7. Intervention Optimum timing for approaching the families, relatives and legal guardians of potential DBD and DCD donors for consent. 8. Comparisons N/A 9. Outcomes Rates of identification of potential donors. Rates of consent for donation. Rates of organ donation for transplantation (donors per million population per year). Rates of conversion for potential donors with consent to actual donors. Rates of successful transplants. Rates of viable organs retrieved. Rates of family, relatives and legal guardians’ refusal. Families, relatives and legal guardians' experience of the structures and processes for organ donation. 10. Other criteria for Exclusion: inclusion/ exclusion The optimal timing for approaching families, relatives of studies and legal guardians of potential DBD and DCD donors for single organs to obtain consent. Groups involved in giving consent on organ donation other than population specified above. Systems for declaring a willingness to donate ante- mortem. Tissue donation The processes of organ retrieval. The structures and process of living organ donation. Assessment of organs for transplantation.

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Organ donation for training and medical research. Prioritisation of organ allocation, including the structures and processes of organ transfers within or outside the UK. 11. Search strategies Please see appendix B. 12. Review strategies Data on all included studies will be extracted into evidence tables. Where statistically possible, a meta-analytic approach will be used to give an overall summary effect. All key outcomes from evidence will be presented in GRADE profiles, or modified evidence profiles depending on the study design, and further summarised in evidence statements.

Details Notes & Status 1. Review question 4 How the care pathway of deceased organ donation should be coordinated to improve potential donors giving consent? 2. Objectives To identify all the relevant literature on structures and processes for the coordination of the care pathway from identification to consent. 3. Language English only 4. Study design No restrictions. 5. Status Published papers (full papers only) 6. Population & Inclusion: Healthcare setting NA Setting: Hospitals 7. Intervention Structures and processes for the coordination of the care pathway from identification to consent. 8. Comparisons N/A 9. Outcomes Rates of identification of potential donors. Rates of consent for donation. Rates of organ donation for transplantation (donors per million population per year). Rates of conversion for potential donors with consent to actual donors. Rates of successful transplants. Rates of viable organs retrieved. Rates of family, relatives and legal guardians’ refusal. Families, relatives and legal guardians' experience of the structures and processes for organ donation. 10. Other criteria for Exclusion: inclusion/exclusion of The coordination of the care pathway for single studies organs to improve potential donors giving consent. Groups involved in giving consent on organ donation other than population specified above. Systems for declaring a willingness to donate ante- mortem. Tissue donation The processes of organ retrieval. The structures and processes of living organ donation. Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 24 of 202

Assessment of organs for transplantation. Organ donation for training and medical research. Prioritisation of organ allocation, including the structures and processes of organ transfers within or outside the UK. 11. Search strategies Please see appendix B. 12. Review strategies Data on all included studies will be extracted into evidence tables. Where statistically possible, a meta-analytic approach will be used to give an overall summary effect. All key outcomes from evidence will be presented in GRADE profiles, or modified evidence profiles depending on the study design, and further summarised in evidence statements.

Details Notes & Status 1. Review question What key skills and competencies are important for 5 healthcare professionals to improve the structures and processes for identifying potential DBD and DCD donors; to improve structures and processes for obtaining consent; and to effectively coordinate the care pathway from identification to obtaining consent? 2. Objectives To identify all the relevant literature on the competencies of healthcare professionals involved in the activities described above. 3. Language English only 4. Study design No restrictions. 5. Status Published papers (full papers only) 6. Population & Inclusion: Healthcare setting Families, relatives and legal guardians of potential DBD and DCD donors (adults and children). • Subgroups considerations: (i) people from black and minority ethnic groups; (ii) people with different religious beliefs. Setting: Hospitals 7. Intervention Key skills and competencies of healthcare professionals involved in the structures and processes for identifying potential DBD and DCD; the structures and processes for obtaining consent; and the coordination of the care pathway from identification to consent. 8. Comparisons N/A 9. Outcomes Rates of identification of potential donors. Rates of consent for donation. Rates of organ donation for transplantation (donors per million population per year). Rates of conversion for potential donors with consent to actual donors. Rates of successful transplants. Rates of viable organs retrieved. Rates of family, relatives and legal guardians’ refusal. Families, relatives and legal guardians' experience of the structures and processes for organ donation. 10. Other criteria for Exclusion:

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 25 of 202

inclusion/ Key skills and competencies for single organ donation. exclusion of Groups involved in giving consent on organ donation studies other than population specified above. Systems for declaring a willingness to donate ante- mortem. Tissue donation. The processes of organ retrieval. The structures and processes of living organ donation. Assessment of organs for transplantation. Organ donation for training and medical research. Prioritisation of organ allocation, including the structures and processes of organ transfers within or outside the UK. 11. Search strategies Please see appendix B. 12. Review strategies Data on all included studies will be extracted into evidence tables. Where statistically possible, a meta-analytic approach will be used to give an overall summary effect. All key outcomes from evidence will be presented in GRADE profiles, or modified evidence profiles depending on the study design, and further summarised in evidence statements.

Excluded studies Review question 1 Aaronson, KD, Schwartz, JS, Chen, TM, Wong, KL, Goin, JE, Mancini, DM Development and prospective validation of a clinical index to predict survival in ambulatory patients referred for cardiac transplant evaluation. Circulation 1997; 95: 2660-2667.

Reason for Exclusion: looking at survival in ambulatory patients referred for cardiac transplant evaluation

Abbud-Filho, M, Ramalho, H, Pires, HS, Silveira, JA Attitudes and awareness regarding organ donation in the western region of Sao Paulo, Brazil. Transplantation Proceedings 1995; 27: 1835.

Reason for Exclusion: surveyed population are not health care professionals

Al Sebayel, MI, Khalaf, H Knowledge and attitude of intensivists toward organ donation in Riyadh, Saudi Arabia. Transplantation Proceedings 2004; 36: 1883-84.

Reason for Exclusion: looking at attitudes towards organ donation

Al-Mousawi, M, Abdul-Razzak, M, Samhan, M Attitude of ICU staff in Kuwait regarding organ donation and brain death. Transplantation Proceedings 2001; 33: 2634-35.

Reason for Exclusion: for q5

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 26 of 202

Antommaria, AH, Bratton, SL Nurses' attitudes toward donation after cardiac death: implications for nurses' roles and moral distress. Pediatric Critical Care Medicine 2008; 9: 339-40.

Reason for Exclusion: for q5

Baines, LS, Joseph, JT, Jindal, RM A public forum to promote organ donation amongst Asians: the Scottish initiative. Transplant International 2002; 15: 124- 31.

Reason for Exclusion: looking at views on organ donation and how to promote it in the Asian community

Barber, K, Falvey, S, Hamilton, C, Collett, D, Rudge, C Potential for organ donation in the United Kingdom: audit of intensive care records. BMJ 2006; 332: 1124-27.

Reason for Exclusion: looks at why potential donors couldn’t end up as actual donors

Beasley, CL, Capossela, CL, Brigham, LE, Gunderson, S, Weber, P, Gortmaker, SL The impact of a comprehensive, hospital-focused intervention to increase organ donation. Journal of Transplant Coordination 1997; 7: 6-13.

Reason for Exclusion: not using clinical triggers or required referral to identify potential donors

Belzer, FO, Kountz, SL Criteria for selection of cadaver donors. Transplantation Proceedings 1972; 4: 591-93.

Reason for Exclusion: not a study

Bener, A, El-Shoubaki, H, Al-Maslamani, Y Do we need to maximize the knowledge and attitude level of physicians and nurses toward organ donation and transplant? Experimental & Clinical Transplantation: Official Journal of the Middle East Society for Organ Transplantation 2008; 6: 249-53.

Reason for Exclusion: for q5

Bledsoe, CM Factors influencing the decision of families to donate organs. 1994; PhD, University of Utah

Reason for Exclusion: British Library can't find it

Bogh, L, Madsen, M Attitudes, knowledge, and proficiency in relation to organ donation: a questionnaire-based analysis in donor hospitals in northern Denmark. Transplantation Proceedings 2005; 37: 3256-57.

Reason for Exclusion: for q5

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 27 of 202

Bohatyrewicz, R, Walecka, A, Bohatyrewicz, A, Zukowski, M, Kepinski, S, Marzec-Lewenstein, E, Sawicki, M, Kordowski, J Unusual movements, "spontaneous" breathing, and unclear cerebral vessels sonography in a brain- dead patient: a case report. Transplantation Proceedings 2007; 39: 2707-8.

Reason for Exclusion: looking at definitive diagnostic tests to confirm BSD

Brown, CVR, Foulkrod, KH, Dworaczyk, S, Thompson, K, Elliot, E, Cooper, H, Coopwood, B Barriers to obtaining family consent for potential organ donors. Journal of Trauma - Injury, Infection and Critical Care 2010; 68: 447-51.

Reason for Exclusion: for q2

Caballero, F, Lopez-Navidad, A, Leal, J, Garcia-Sousa, S, Soriano, JA, Domingo, P The cultural level of cadaveric potential organ donor relatives determines the rate of consent for donation. Transplantation Proceedings 1999; 31: 2601.

Reason for Exclusion: for q2

Cameron, AM, Ghobrial, RM Utilization of extended criteria donors. Current Opinion in Organ Transplantation 2007; 12: 119-24.

Reason for Exclusion: looking at using criteria to identify potential donors

Cherkassky, L Presumed consent in organ donation: is the duty finally upon us? European Journal of Health Law 2010; 17: 149-64.

Reason for Exclusion: general background

Cheung, AH, Alden, DL, Wheeler, MS Cultural attitudes of Asian-Americans toward death adversely impact organ donation. Transplantation Proceedings 1998; 30: 3609-10.

Reason for Exclusion: for q2

Cheung, AH, Luna, GK Cadaveric organ donor availability: regional trauma center vs. community hospital. Journal of Trauma-Injury Infection & Critical Care 1990; 30: 1366-71.

Reason for Exclusion: not using clinical triggers or required referral in the study

Childress, JF The failure to give: reducing barriers to organ donation. Kennedy Institute of Ethics Journal 2001; 11: 1-16.

Reason for Exclusion: general background

Chung, CS, Lehmann, LS Informed consent and the process of cadaver donation. Archives of Pathology and Laboratory Medicine 2002; 126: 964-68.

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Reason for Exclusion: for q2

Coleman, N, Brieva, J, Crowfoot, E Identification of a realistic donation after cardiac death (DCD) donor: predicting time of death within 60 minutes following withdrawal of futile life sustaining treatment. Transplant Nurses' Journal 2008; 17: 22-26.

Reason for Exclusion: British Library can't find it

Colpart, JJ, Bouttin, B, Guillot, B, Maillefaud, B, Marion, A, Saury, G, Leone, C, Minarro, D, Moskovtchenko, JF Logistics and management for improvement of multiorgan procurement from potential brain-dead donors. Transplantation Proceedings 1996; 28: 264-65.

Reason for Exclusion: looking at organ retrieval rather than identification

Criteria for organ donors. IMJ - Illinois Medical Journal 1987; 171: 309-10.

Reason for Exclusion: not a study

Denny, DW Now more than ever, doctors must help in finding organ donors. Medical World News 1983; 24: 110.

Reason for Exclusion: not a study

DeVita, MA, Brooks, MM, Zawistowski, C, Rudich, S, Daly, B, Chaitin, E Donors after cardiac death: validation of identification criteria (DVIC) study for predictors of rapid death. American Journal of Transplantation 2008; 8: 432- 41.

Reason for Exclusion: looking at using specific criteria to predict death within 60minutes after withdrawal of life support

DeVita, MA, Snyder, JV Development of the University of Pittsburgh Medical Center policy for the care of terminally ill patients who may become organ donors after death following the removal of life support. Kennedy Institute of Ethics Journal 1993; 3: 131-43.

Reason for Exclusion: description of services and not evaluation

DeVita, MA, Webb, SA, Hurford, WE, Truog, RD, Wlody, GS, Hayden, CT, Sprung, CL, Brilli, RJ, Beals, DA, Rothenberg, DM, Friedman, AL, Silverstein, DS, Kaufman, DC, Perkin, RM, Rosenbaum, SH, Cist, AFM, Samotowka, M, Teres, D, Unkle, DW, Burns, JP, Wallace, TE Recommendations for nonheartbeating organ donation. Critical Care Medicine 2001; 29: 1826-31.

Reason for Exclusion: general background

DeYoung, S, Temmler, L, Adams, EF, Just, G Organ referrals--would nurses do more if they knew more? Journal of Continuing Education in Nursing 1991;

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22: 219-21.

Reason for Exclusion: survey of nurses but not on clinical triggers or care pathway

Douglas, S Factors affecting cadaveric organ donation: a national survey of organ procurement coordinators. Journal of Transplant Coordination 1994; 4: 96-103.

Reason for Exclusion: for q2

Durall, AL, Laussen, PC, Randolph, AG Potential for donation after cardiac death in a children's hospital. Pediatrics 2007; 119: e219-e224.

Reason for Exclusion: looks at identification of potential donors after DCD

Edwards, J, Mulvania, P, Robertson, V, George, G, Hasz, R, Nathan, H, D'Alessandro, A Maximizing organ donation opportunities through donation after cardiac death. [Review] [25 refs]. Critical Care Nurse 2006; 26: 101-15.

Reason for Exclusion: general background

Edwards, JM, Hasz, RD, Jr., Robertson, VM Non-heart-beating organ donation: process and review. [Review] [21 refs]. AACN Clinical Issues 1999; 10: 293-300.

Reason for Exclusion: general background

Ehrle, R Timely referral of potential organ donors. [Review] [36 refs][Reprint in Prog Transplant. 2008 Mar;18(1):17-21; PMID: 18429577]. Critical Care Nurse 2006; 26: 88-93.

Reason for Exclusion: general background

Ehrle, RN, Shafer, TJ, Nelson, KR Referral, request, and consent for organ donation: best practice--a blueprint for success. [Review] [66 refs]. Critical Care Nurse 1932; 19: 21-30.

Reason for Exclusion: British Library can't find it

Evans, RW, Orians, CE, Ascher, NL The potential supply of organ donors. An assessment of the efficacy of organ procurement efforts in the United States. JAMA 1992; 267: 239-46.

Reason for Exclusion: used certain criteria to identify donors and also looked at donor procurement

Fecteau, A, Atkinson, P, Grant, D Early referral is essential for successful pediatric small bowel transplantation: The Canadian experience. Journal of Pediatric Surgery 2001; 36: 681-84.

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Reason for Exclusion: looking at outcomes of patients who undergo small bowel transplantation

Ferguson, M, Zuk, J Organ donation after cardiac death: A new trend in pediatrics. Journal of Pediatric Gastroenterology and Nutrition 2003; 37: 219- 20.

Reason for Exclusion: not a study

Freebury, DR The psychological implications of organ transplantation. A selective review. [Review] [16 refs]. Canadian Psychiatric Association Journal 1974; 19: 593-97.

Reason for Exclusion: literature search

Frezza, EE, Krefski, LR, Valenziano, CP Factors influencing the potential organ donation: a 6-yr experience of the New Jersey Organ and Tissue Sharing Network. Clinical Transplantation 1999; 13: 231-40.

Reason for Exclusion: doesn’t show how to increase donor identification

Frutos, MA, Ruiz, P, Requena, MV, Daga, D Family refusal in organ donation: Analysis of three patterns. Transplantation Proceedings 2002; 34: 2513-14.

Reason for Exclusion: for q2

Gabel, H Continuous registration of potential cadaveric donors in Sweden, May 1989- December 1991. Journal of Transplant Coordination 1993; 3: 134- 38.

Reason for Exclusion: not a study

Gabel, H, Roels, L Legislative initiatives to increase donation. Transplantation Proceedings 1997; 29: 3223.

Reason for Exclusion: not a study

Garcia, VD, Garcia, CD, Keitel, E, Santos, AF, Bianco, PD, Bittar, AE, Neumann, J, Campos, HH, Pestana, JOM, Abbud-Filho, M Expanding criteria for the use of living donors: What are the limits? Transplantation Proceedings 2004; 36: 808-10.

Reason for Exclusion: looking at living donors which is not part of our population

Glasson, J, Plows, CW, Tenery, J, Clarke, OW, Ruff, V, Fuller, D, Kliger, CH, Wilkins, J, Cosgriff, J, Orentlicher, D, Harwood, K, Leslie, J Strategies for cadaveric organ procurement: Mandated choice and presumed consent. Journal of the American Medical Association 1994; 272: 809-12.

Reason for Exclusion: not a study

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 31 of 202

Gravel, MT, Szeman, P Increasing referrals and donations using the Transplant Center Development Model. Journal of Transplant Coordination 1996; 6: 32-36.

Reason for Exclusion: not using clinical triggers or required referral in the study

Gronda, EG, Barbieri, P, Frigerio, M, Mangiavacchi, M, Oliva, F, Quaini, E, Andreuzzi, B, Garascia, A, De, VC, Pellegrini, A Prognostic indices in heart transplant candidates after the first hospitalization triggered by the need for intravenous pharmacologic circulatory support. Journal of Heart & Lung Transplantation 1999; 18: 654-63.

Reason for Exclusion: looking at interventions to improve outcomes in patients with endstage heart failure

Hagan, ME, McClean, D, Falcone, CA, Arrington, J, Matthews, D, Summe, C Attaining specific donor management goals increases number of organs transplanted per donor: a quality improvement project. Progress in Transplantation 2009; 19: 227-31.

Reason for Exclusion: not looking at clinical triggers but rather change in processes to increase identification

Hardison, J, Schears, RM Organ donation after cardiac death: a reexamination of healthcare provider attitudes. Critical Care Medicine 2007; 35: 2666-67.

Reason for Exclusion: letter to editor

Hassan, TB, Joshi, M, Quinton, DN, Elwell, R, Baines, J, Bell, PR Role of the accident and emergency department in the non-heart-beating donor programme in Leicester. Journal of Accident & Emergency Medicine 1996; 13: 321-24.

Reason for Exclusion: not looking at clinical triggers and no baseline comparison

Henderson, SO, Chao, JL, Green, D, Leinen, R, Mallon, WK Organ procurement in an urban level I emergency department. Annals of Emergency Medicine 1998; 31: 466-70.

Reason for Exclusion: looking at benefits of educating staff to increase identification

Jouan, MC, Decaris, J, Bicocchi, C, Joseph, L, Claquin, J, Villiers, S Analysis of organ donation refusal. Transplantation Proceedings 1996; 28: 388-89.

Reason for Exclusion: for q2

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 32 of 202

Keenan, SP, Hoffmaster, B, Rutledge, F, Eberhard, J, Chen, LM, Sibbald, WJ Attitudes regarding organ donation from non-heart-beating donors. Journal of Critical Care 1937; 17: 29-36.

Reason for Exclusion: looking at attitudes of the public towards organ donation

Kittur, DS, McMenamin, J, Knott, D Impact of an organ donor and tissue donor advocacy program on community hospitals. American Surgeon 1990; 56: 36-39.

Reason for Exclusion: not using clinical triggers or required referral in the study

Kmietowicz, Z Taskforce rejects system of presumed consent for organ donation in UK. BMJ 2008; 337: a2621.

Reason for Exclusion: British Library can't find it

Koenig, BA Dead donors and the "shortage" of human organs: are we missing the point? American Journal of Bioethics 2003; 3: 26-27.

Reason for Exclusion: not a study

Kowalski, AE, Light, JA, Ritchie, WO, Sasaki, TM, Callender, CO, Gage, F A new approach for increasing the organ supply. Clinical Transplantation 1996; 10: t-7.

Reason for Exclusion: not a study

Kozlowski, LM Case study in identification and maintenance of an organ donor. Heart & Lung 1988; 17: 366-71.

Reason for Exclusion: describes the process of organ donation

Kwek, TK, Lew, TW, Tan, HL, Kong, S The transplantable organ shortage in Singapore: has implementation of presumed consent to organ donation made a difference?. [Review] [30 refs]. Annals of the Academy of Medicine, Singapore 2009; 38: 346-48.

Reason for Exclusion: general background

La, SF, Sedda, L, Pizzi, C, Verlato, R, Boselli, L, Candiani, A, Chiaranda, M, Frova, G, Gorgerino, F, Gravame, V, Mapelli, A, Martini, C, Pappalettera, M, Seveso, M, Sironi, PG Donor families' attitude toward organ donation. Transplantation Proceedings 1993; 25: 1699-701.

Reason for Exclusion: for q2

Lawton, RL, Davis, J Importance of recent legislation regarding the recognition of brain death, and the identification of organ donors. Journal of

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the Iowa Medical Society 1977; 67: 11-13.

Reason for Exclusion: general background

Leslie, GD The "Spanish Model"--an initiative aimed at increasing organ donation rates in Australia. Australian Critical Care 1995; 8: 33-34.

Reason for Exclusion: general background

Mackersie, RC, Bronsther, OL, Shackford, SR Organ procurement in patients with fatal head injuries. The fate of the potential donor. Annals of Surgery 1991; 213: 143-50.

Reason for Exclusion: looks at organ procurement rather than identification

Martinez, JM, Lopez, JS, Martin, A, Martin, MJ, Scandroglio, B, Martin, JM Organ donation and family decision-making within the Spanish donation system. Social Science & Medicine 2001; 53: 405-21.

Reason for Exclusion: for q2

Matesanz, R, Bozzi, G, Saviozzi, AR, Ferrini, PL, Cardone, A, Tuscany Nurse, TC How to evaluate organ donation: the quality programme in Tuscany. Edtna-Erca Journal 2004; 30: 38-41.

Reason for Exclusion: looking at implementing better processes to improve identification

Molzahn, AE Knowledge and attitudes of critical care nurses regarding organ donation. Canadian Journal of Cardiovascular Nursing 1997; 8: 13-19.

Reason for Exclusion: for q5

O'Brien, RL, Serbin, MF, O'Brien, KD, Maier, RV, Grady, MS Improvement in the organ donation rate at a large urban trauma center. Archives of Surgery 1996; 131: 153-59.

Reason for Exclusion: not using clinical triggers or required referral in the study

Opdam, HI, Silvester, W Erratum: "Potential for organ donation in Victoria: An audit of hospital deaths" (Medical Journal of Australia (2006) vol. 185 (250- 254)). Medical Journal of Australia 2006; 185: 408.

Reason for Exclusion: letter to editor

Pearson, IY The potential organ donor. Medical Journal of Australia 1993; 158: 45-47.

Reason for Exclusion: general background

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 34 of 202

Pearson, IY, Bazeley, P, Spencer-Plane, T, Chapman, JR, Robertson, P A survey of families of brain dead patients: Their experiences, attitudes to organ donation and transplantation. Anaesthesia and Intensive Care 1995; 23: 88- 95.

Reason for Exclusion: for q2

Prottas, J Shifting responsibilities in organ procurement: a plan for routine referral. JAMA 1988; 260: 832-33.

Reason for Exclusion: not a study

Quaghebeur, B, van, GF, Roels, L, Daenen, W, van den Berghe, G Potential for Hb and nHb organ donation: a retrospective medical record review on 7 critical care units in a 1900 bed hospital. CONNECT: The World of Critical Care Nursing 2005; 4: 85-87.

Reason for Exclusion: British Library can't find it

Ranjan, D, Schmonsky, K, Johnston, T, Jeon, H, Bouneva, I, Erway, E Financial analysis of potential donor management at a medicare-approved transplant hospital. American Journal of Transplantation 2006; 6: 199-204.

Reason for Exclusion: looking at financial incentives and organ donation

Razek, T, Olthoff, K, Reilly, PM Issues in potential organ donor management. [Review] [75 refs]. Surgical Clinics of North America 2000; 80: 1021-32.

Reason for Exclusion: general background

Rios, A, Conesa, C, Ramirez, P, Galindo, PJ, Rodriguez, JM, Rodriguez, MM, Martinez, L, Parrilla, P, Redes Tematicas de Investigacion Cooperativa: Estrategias para Optimizar los Resultados en Donacion Attitudes of resident doctors toward different types of organ donation in a Spanish transplant hospital. Transplantation Proceedings 2006; 38: 869-74.

Reason for Exclusion: looks at attitudes of resident doctors towards organ donation

Rios, A, Lopez-Navas, A, Ayala, MA, Sebastian, MJ, Martinez-Alarcon, L, Ramirez, EJ, Munoz, G, Camacho, A, Lopez-Lopez, A, Rodriguez, JS, Martinez, MA, Nieto, A, Ramirez, P, Parrilla, P Attitudes of Spanish and Mexican resident physicians faced with solid organ donation and transplantation. Transplantation Proceedings 2010; 42: 233-38.

Reason for Exclusion: looks at attitudes towards organ donation and not identification

Rios, ZA, Ramirez, P, Martinez, L, Montoya, MJ, Lucas, D, Alcaraz, J, Rodriguez, MM, Rodriguez, JM, Parrilla, P Are personnel in transplant hospitals in favor of cadaveric organ donation? Multivariate attitudinal study in

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a hospital with a solid organ transplant program. Clinical Transplantation 2006; 20: 743-54.

Reason for Exclusion: for q5

Roth, BJ, Sher, L, Murray, JA, Belzberg, H, Mateo, R, Heeran, A, Romero, J, Mone, T, Chan, L, Selby, R Cadaveric organ donor recruitment at Los Angeles County Hospital: improvement after formation of a structured clinical, educational and administrative service. Clinical Transplantation 2003; 17: Suppl-7.

Reason for Exclusion: not using clinical triggers or required referral in the study

Roza, BA, Pestana, JO, Barbosa, SF, Schirmer, J Organ donation procedures: an epidemiological study. Progress in transplantation (Aliso Viejo, Calif ) 2010; 20: 88-95.

Reason for Exclusion: for q2

Roza, BA, Pestana, JO, Barbosa, SF, Schirmer, J Organ donation procedures: an epidemiological study. Progress in Transplantation 2010; 20: 88-95.

Reason for Exclusion: duplicate

Rutter, N, Mann, NP, Watson, AR Organ donation. Archives of Disease in Childhood 1989; 64: 875-78.

Reason for Exclusion: not a study

Sade, RM, Kay, N, Pitzer, S, Drake, P, Baliga, P, Haines, S Increasing organ donation: a successful new concept. Transplantation 2002; 74: 1142-46.

Reason for Exclusion: looking at identifying potential donors using counselling and education services

Saeed, B, Derani, R, Hajibrahim, M, Roumani, J, Al-Shaer, MB, Saeed, R, Damerli, S, Al-Saadi, R, Kayyal, B, Haddad, M Organ failure in Syria: initiating a national deceased donation program. [Review] [34 refs]. Saudi Journal of Kidney Diseases & Transplantation 2007; 18: 270-276.

Reason for Exclusion: looking at liking organ donation failure and a national programme

Saeed, B, Derani, R, Hajibrahim, M, Roumani, J, Al-Shaer, MB, Saeed, R, Damerli, S, Al-Saadi, R, Kayyal, B, Haddad, M Volume of organ failure in Syria and obstacles to initiate a national cadaver donation program. Iranian journal of Kidney Diseases 2008; 2: 65-71.

Reason for Exclusion: not a study

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Salih, MA, Harvey, I, Frankel, S, Coupe, DJ, Webb, M, Cripps, HA Potential availability of cadaver organs for transplantation. BMJ 1991; 302: 1053-55.

Reason for Exclusion: looking at using specific criteria to identify donors for kidney transplantation

Salim, A, Velmahos, GC, Brown, C, Belzberg, H, Demetriades, D Aggressive organ donor management significantly increases the number of organs available for transplantation. Journal of Trauma-Injury Infection & Critical Care 2005; 58: 991-94.

Reason for Exclusion: looking at implementing better management of potential donors to increase donation rather than clinical triggers

Sanner, MA Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Journal of Critical Care 2007; 22: 296-304.

Reason for Exclusion: for q2

Shafer, T, Hueneke, M, Wolff, S, Davis, K, Ehrle, R, Van, BC, Orlowski, J, White, C The Texas Nondonor Hospital Project: a preliminary report on the impact of inhouse coordinators on organ donation rates in nondonor hospitals. Transplantation Proceedings 1997; 29: 3261-62.

Reason for Exclusion: a report on a paper

Shafer, TJ, Van Buren, CT, Andrews, CA Program development and routine notification in a large, independent OPO: a 12-year review. Journal of Transplant Coordination 1999; 9: 40-49.

Reason for Exclusion: comment on another study

Shaw, AB Non-therapeutic (elective) ventilation of potential organ donors: the ethical basis for changing the law. Journal of Medical Ethics 1996; 22: 72-77.

Reason for Exclusion: general background

Shemie, SD, Baker, AJ, Knoll, G, Wall, W, Rocker, G, Howes, D, Davidson, J, Pagliarello, J, Chambers-Evans, J, Cockfield, S, Farrell, C, Glannon, W, Gourlay, W, Grant, D, Langevin, S, Wheelock, B, Young, K, Dossetor, J National recommendations for donation after cardiocirculatory death in Canada: Donation after cardiocirculatory death in Canada. CMAJ Canadian Medical Association Journal 2006; 175: S1.

Reason for Exclusion: background

Shirley, S, Cutler, J, Heymann, C, Hart, M Narrowing the organ donation gap: hospital development methods that maximize hospital donation potential. Journal of Heart & Lung Transplantation 1994; 13: 817-23.

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Reason for Exclusion: not using clinical triggers or required referral in the study

Siminoff, LA, Arnold, RM, Hewlett, J The process of organ donation and its effect on consent. Clinical Transplantation 2001; 15: 39-47.

Reason for Exclusion: for q2

Siminoff, LA, Lawrence, RH Knowing patients' preferences about organ donation: does it make a difference? Journal of Trauma-Injury Infection & Critical Care 2002; 53: 754-60.

Reason for Exclusion: for q2

Siminoff, LA, Traino, HM Improving donation outcomes: hospital development and the Rapid Assessment of Hospital Procurement Barriers in Donation. Progress in Transplantation 2009; 19: 180-187.

Reason for Exclusion: looking at barriers to organ donation

Singer, P, Rachmani, R Improving attitude and knowledge of healthcare professionals towards organ donation in Israel: results of 12 European donor hospital education programs. Transplantation Proceedings 1997; 29: 3244- 45.

Reason for Exclusion: for q5

Sohrabi, S, Navarro, A, Asher, J, Wilson, C, Sanni, A, Wyrley-Birch, H, Anand, V, Reddy, M, Rix, D, Jacques, B, Manas, D, Talbot, D Agonal period in potential non-heart-beating donors. Transplantation Proceedings 2006; 38: 2629-30.

Reason for Exclusion: looks at time interval for retrieval of organs

Soifer, BE, Gelb, AW The multiple organ donor: Identification and management. Annals of Internal Medicine 1989; 110: 814-23.

Reason for Exclusion: general background

Studer, SM, Orens, JB Cadaveric donor selection and management. [Review] [51 refs]. Respiratory Care Clinics of North America 2004; 10: 459-71.

Reason for Exclusion: general background

Studer, SM, Orens, JB Cadaveric donor selection and management. Seminars in Respiratory and Critical Care Medicine 2006; 27: 492-500.

Reason for Exclusion: duplicate

Sullivan, H, Blakely, D, Davis, K An in-house coordinator program to increase organ donation in public teaching hospitals. Journal of Transplant

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Coordination 1998; 8: 40-42.

Reason for Exclusion: British Library can't find it

Sutherland, S Nurse coordinator--European experience organizing development in UK transplant--a nurse-based system. Transplantation Proceedings 2003; 35: 992-94.

Reason for Exclusion: a report

Tenn-Lyn, NA, Doig, CJ, Shemie, SD, Teitelbaum, J, Cass, DE Potential organ donors referred to Ontario neurosurgical centres. Canadian Journal of Anaesthesia 2006; 53: 732-36.

Reason for Exclusion: not using clinical triggers or required referral in the study

UNOS criteria identify candidates for organ donation after cardiac death. Nature Clinical Practice Nephrology 2008; 4: 242.

Reason for Exclusion: expert comment on a study

Waller, JA, Haisch, CE, Skelly, JM Potential availability of transplantable organs according to factors associated with type of injury event. Accident Analysis & Prevention 1992; 24: 193-200.

Reason for Exclusion: looking at viability of transplantable organs from different sources

Waller, JA, Haisch, CE, Skelly, JM, Goldberg, CG Potential availability of transplantable organs and tissues in fatalities from injury and nontraumatic intracranial hemorrhage. Transplantation 1993; 55: 542-46.

Reason for Exclusion: studying time intervals between retrieval and identification of organs

Wight, C Two initiatives designed to maximize the potential for organ donation from intensive care units. Annals of Transplantation 1998; 3: 13-17.

Reason for Exclusion: for q5

Wight, C, Cohen, B, Miranda, B, Fernandez, M, Beasley, C Hospital attitudes: preliminary findings from donor action pilot projects. Transplant International 1998; 11: Suppl-9.

Reason for Exclusion: for q5

Williams, MA, Lipsett, PA, Rushton, CH, Grochowski, EC, Berkowitz, ID, Mann, SL, Shatzer, JH, Short, MP, Genel, M, Council on Scientific Affairs, AMA The physician's role in discussing organ donation with families. [Review] [39 refs]. Critical Care Medicine 2003; 31: 1568-73.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 39 of 202

Reason for Exclusion: not a study

Review question 2 Brain death cases reported, medically documented, families approached, consented for donation and harvested from different hospitals in Saudi Arabia in 2005. Saudi Journal of Kidney Diseases & Transplantation 2006; 17: 262- 70.

Reason for Exclusion: not a study

Brain death cases reported, medically documented, families approached, consented for donation and harvested from different hospitals in Saudi Arabia in 2006. Saudi Journal of Kidney Diseases & Transplantation 2007; 18: 287- 98.

Reason for Exclusion: not a study

Strategies for cadaveric organ procurement. Mandated choice and presumed consent. Council on Ethical and Judicial Affairs, American Medical Association. JAMA 1994; 272: 809-12.

Reason for Exclusion: general background

Abadie, A, Gay, S The impact of presumed consent legislation on cadaveric organ donation: a cross-country study. Journal of Health Economics 2006; 25: 599-620.

Reason for Exclusion: general background

Abbing, HD Organ donation, the legal framework. Health Policy 1990; 16: 105-15.

Reason for Exclusion: general background

Abouna, GM Organ shortage crisis: problems and possible solutions. Transplantation Proceedings 2008; 40: 34-38.

Reason for Exclusion: general background

Afonso, RC, Pinheiro, R, Santos-Junior, PRM, Bussolaro, RA, Ferraz-Neto, BH, Roza, B, Freitas, JE, Lessa, B Notifying potential donors: Perspective of help from the intra-hospital transplantation committee. Transplantation Proceedings 2002; 34: 445-46.

Reason for Exclusion: looks at identification rather than consent

Aksoy, S A critical approach to the current understanding of Islamic scholars on using cadaver organs without prior permission. Bioethics 2001; 15: 461- 72.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 40 of 202

Reason for Exclusion: general background

Al-Mousawi, M, Hamed, T, al-Matouk, H Views of Muslim scholars on organ donation and brain death. Transplantation Proceedings 1997; 29: 3217.

Reason for Exclusion: looking at views of Muslim scholars towards organ donation and not consent

Aldridge, A, Guy, BS Deal breakers in the organ donation request process. Health Marketing Quarterly 2008; 23: 17-31.

Reason for Exclusion: general background

Barber, K, Falvey, S, Hamilton, C, Collett, D, Rudge, C Potential for organ donation in the United Kingdom: audit of intensive care records. BMJ 2006; 332: 1124-27.

Reason for Exclusion: looks at potential for organ donation and not consent

Beaulieu, D Organ donation: the family's right to make an informed choice. [Review] [25 refs]. Journal of Neuroscience Nursing 1999; 31: 37-42.

Reason for Exclusion: literature search

Benoit, G, Spira, A, Nicoulet, I, Moukarzel, M Presumed consent law: results of its application/outcome from an epidemiologic survey. Transplantation Proceedings 1990; 22: 320-322.

Reason for Exclusion: looking at presumed consent law which is not practiced in UK

Bernat, JL, D'Alessandro, AM, Port, FK, Bleck, TP, Heard, SO, Medina, J, Rosenbaum, SH, DeVita, MA, Gaston, RS, Merion, RM, Barr, ML, Marks, WH, Nathan, H, O'Connor, K, Rudow, DL, Leichtman, AB, Schwab, P, Ascher, NL, Metzger, RA, Mc, B, V, Graham, W, Wagner, D, Warren, J, Delmonico, FL Report of a national conference on donation after cardiac death. American Journal of Transplantation 2006; 6: 281-91.

Reason for Exclusion: report of a conference

Bledsoe, CM Factors influencing the decision of families to donate organs. jj 1994; -NaN.

Reason for Exclusion: British Library can't find it

Blok, GA, Morton, J, Morley, M, Kerckhoffs, CC, Kootstra, G, van der Vleuten, CP Requesting organ donation: the case of self-efficacy--effects of the European Donor Hospital Education Programme (EDHEP). Advances in Health Sciences Education 2004; 9: 261-82.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 41 of 202

Reason for Exclusion: general background

Blok, GA The impact of changes in practice in organ procurement on the satisfaction of donor relatives. Patient Education & Counseling 2005; 58: 104- 13.

Reason for Exclusion: British Library can't find it

Brazier, M Organ retention and return: problems of consent. Journal of Medical Ethics 2003; 29: 30-33.

Reason for Exclusion: a symposium presentation

Caillouet-O'Neal, C, Booker, QG Converting family advocates to level 1 recovery coordinators. Transplantation Proceedings 2008; 40: 1041-43.

Reason for Exclusion: looking at effects of family advocates on recovery of organs

Carey, I, Forbes, K The experiences of donor families in the hospice. Palliative Medicine 2003; 17: 241-47.

Reason for Exclusion: looking at tissue donation

Cheng, B, Ho, C-P, Ho, S, Wong, A An overview on attitudes towards organ donation in Hong Kong. Hong Kong Journal of Nephrology 2005; 7: 77-81.

Reason for Exclusion: looking at general attitudes towards organ donation rather than consent

Cheung, AH, Alden, DL, Wheeler, MS Cultural attitudes of Asian-Americans toward death adversely impact organ donation. Transplantation Proceedings 1998; 30: 3609-10.

Reason for Exclusion: looking at cultural differences in attitude towards organ donation

Choo, V UK Shariah Council approves organ transplants. Lancet 1995; 346: 303.

Reason for Exclusion: general background

Christmas, AB, Mallico, EJ, Burris, GW, Bogart, TA, Norton, HJ, Sing, RF A paradigm shift in the approach to families for organ donation: Honoring patients' wishes versus request for permission in patients with department of motor vehicles donor designations. Journal of Trauma - Injury, Infection and Critical Care 2008; 65: 1507-9.

Reason for Exclusion: looking at honouring patient's wishes rather than asking for permission from relatives which is not practiced in the UK

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 42 of 202

Chrysler, GR Consent for cadaver organ and tissue donation. Journal of Transplant Coordination 1998; 8: 72-73.

Reason for Exclusion: letter to editor

Chung, CS, Lehmann, LS Informed consent and the process of cadaver donation. Archives of Pathology & Laboratory Medicine 2002; 126: 964-68.

Reason for Exclusion: setting is medical school and not hospitals

Chung, CS, Lehmann, LS Informed consent and the process of cadaver donation. Archives of Pathology and Laboratory Medicine 2002; 126: 964-68.

Reason for Exclusion: setting is medical school and not hospitals and duplicate

Collins, M Consent for organ retrieval cannot be presumed. HEC Forum 2009; 21: 71-106.

Reason for Exclusion: general background

Dimond, B Law concerning organ transplants and dead donors in the UK. [Review] [4 refs]. British Journal of Nursing 2005; 14: 47-48.

Reason for Exclusion: not a study

Duguet, AM, Pujos, M, Le, TA, Gilbert-Calvet, C, Grezes-Rueff, C Organ removal from children and minors. Information and parents' consent. Acta Medicinae Legalis et Socialis 1987; 37: 53-58.

Reason for Exclusion: general background

Ebrahim, AF Organ transplantation: contemporary Sunni Muslim legal and ethical perspectives. Bioethics 1995; 9: 291-302.

Reason for Exclusion: not a study

Floden, A, Kelvered, M, Frid, I, Backman, L Causes why organ donation was not carried out despite the deceased being positive to donation. [Review] [20 refs]. Transplantation Proceedings 2006; 38: 2619-21.

Reason for Exclusion: literature search

Gallagher, C Religious attitudes regarding organ donation. Journal of Transplant Coordination 1996; 6: 186-91.

Reason for Exclusion: looks at religious attitudes towards organ donation and not consent

Gallagher, C Religious attitudes regarding organ donation. [Review] [17 refs]. Journal of Transplant Coordination 1996; 6: 186-90.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 43 of 202

Reason for Exclusion: looks at religious attitudes towards organ donation and not consent

Glasson, J, Plows, CW, Tenery, J, Clarke, OW, Ruff, V, Fuller, D, Kliger, CH, Wilkins, J, Cosgriff, J, Orentlicher, D, Harwood, K, Leslie, J Strategies for cadaveric organ procurement: Mandated choice and presumed consent. Journal of the American Medical Association 1994; 272: 809-12.

Reason for Exclusion: not a study

Gore, SM, Hinds, CJ, Rutherford, AJ Organ donation from intensive care units in England. BMJ 1989; 299: 1193-97.

Reason for Exclusion: looking at identification of donors

Griffith, R, Tengnah, C Consent to organ donation part 1: the current arrangements. British Journal of Community Nursing 2009; 14: 544-47.

Reason for Exclusion: general background

Hardison, J, Schears, RM Organ donation after cardiac death: A reexamination of healthcare provider attitudes [3]. Critical Care Medicine 2007; 35: 2666.

Reason for Exclusion: letter to editor

Harrison, CH, Laussen, PC Controversy and consensus on pediatric donation after cardiac death: ethical issues and institutional process. Transplantation Proceedings 2008; 40: 1044-47.

Reason for Exclusion: general background

Hoehn, KS, Frader, JE Approaching parents for organ donation: Who and when? Pediatric Critical Care Medicine 2008; 9: 234-35.

Reason for Exclusion: not a study

Howard, DH, Siminoff, LA, McBride, V, Lin, M Does quality improvement work? Evaluation of the organ donation breakthrough collaborative. Health Services Research 2007; 42: 2160-2173.

Reason for Exclusion: looking at effects of best practices on conversion of potential donors becoming actual donors rather than obtaining consent

Jansen, NE, Haase-Kromwijk, BJ, van Leiden, HA, Weimar, W, Hoitsma, AJ A plea for uniform European definitions for organ donor potential and family refusal rates. Transplant International 2009; 22: 1064-72.

Reason for Exclusion: literature search

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 44 of 202

Johnson, R, Reid, S, Lichty, S, Edelstein, C, Stuber, J Helping a family through the organ donation process. Nursing 2000; 30: 52-55.

Reason for Exclusion: general background

Knowles, D Parents' consent to the post-mortem removal and retention of organs. Journal of Applied Philosophy 2001; 18: 215-27.

Reason for Exclusion: general background

Leflar, RB Informed consent and patients' rights in Japan. Houston Law Review 1996; 33: 1-112.

Reason for Exclusion: general background

Lock, M Cultural aspects of organ donation and transplantation. Transplantation Proceedings 1999; 31: 1345-46.

Reason for Exclusion: general background

Lombardo, PA Consent and "donations' from the dead. Hastings Center Report 1981; 11: 9-11.

Reason for Exclusion: general background

Marks, WH, Wagner, D, Pearson, TC, Orlowski, JP, Nelson, PW, McGowan, JJ, Guidinger, MK, Burdick, J Organ donation and utilization, 1995-2004: Entering the collaborative era. American Journal of Transplantation 2006; 6: 1101-10.

Reason for Exclusion: general background

Matesanz, R, Dominguez-Gil, B Strategies to optimize deceased organ donation. Transplantation Reviews 2007; 21: 177-88.

Reason for Exclusion: general background

Mavroforou, A, Giannoukas, A, Michalodimitrakis, E Consent for organ and tissue retention in British law in the light of the Human Tissue Act 2004. Medicine & Law 2006; 25: 427-34.

Reason for Exclusion: general background

Mavroforou, A, Giannoukas, A, Michalodimitrakis, E Consent for organ and tissue retention in british law in the light of the human tissue act 2004. Medicine and Law 2006; 25: 427-34.

Reason for Exclusion: general background and duplicate

Metzger, RA, Taylor, GJ, McGaw, LJ, Weber, PG, Delmonico, FL, Prottas, JM, UNOS Research to Practice Steering Committee Research to practice: a

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 45 of 202

national consensus conference. [9 refs]. Progress in Transplantation 2005; 15: 379-84.

Reason for Exclusion: conference findings

Montefusco, CM, Levine, S, Goldsmith, J, Veith, FJ Obtaining consent for organ donation. Hospital Physician 1985; 21: 46-50.

Reason for Exclusion: general background

Morgan, V Brain stem death testing and consent for cadaveric organ donation. Care of the Critically Ill 1995; 11: 20-22.

Reason for Exclusion: general background

Morgan, SE, Harrison, TR, Long, SD, Afifi, WA, Stephenson, MT, Reichert, T Family discussions about organ donation: how the media influences opinions about donation decisions.[Erratum appears in Clin Transplant. 2005 Dec;19(6):848 Note: Stephenson, Michael S [corrected to Stephenson, Michael T]]. Clinical Transplantation 2005; 19: 674-82.

Reason for Exclusion: setting is not hospitals but rather homes

Morton, J In support of the consent process for organ donation from deceased persons. New Zealand Medical Journal 2004; 117: U1041.

Reason for Exclusion: not a study

Noury, D, Carre, P, Auger, E, Le Sant, JN, Pinault, MF, Jacob, F Preliminary results of a survey on the information of families of organ and tissue donors. Transplantation Proceedings 1995; 27: 1660-1661.

Reason for Exclusion: complete results not reported

Olick, RS Approximating informed consent and fostering communication: the anatomy of an advance directive. Journal of Clinical Ethics 1991; 2: 181-89.

Reason for Exclusion: not a study

Opdam, HI, Silvester, W Potential for organ donation in Victoria: An audit of hospital deaths. Medical Journal of Australia 2006; 185: 250-254.

Reason for Exclusion: looking at identification of potential donors rather than obtaining consent

Pellegrino, ED Families' self-interest and the cadaver's organs. What price consent? JAMA 1991; 265: 1305-6.

Reason for Exclusion: not a study

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 46 of 202

Rady, MY, Verheijde, JL, Ali, MS Islam and end-of-life practices in organ donation for transplantation: New questions and serious sociocultural consequences. HEC Forum 2009; 21: 175-205.

Reason for Exclusion: general background

Ridley, S, Bonner, S, Bray, K, Falvey, S, Mackay, J, Manara, A, Bodenham, A, Dougall, J, Doyle, P, Farquhar, I, McElligot, M, Pittard, A, Rudge, C, Taylor, B, Tollerton, H, Tullet, W UK guidance for non-heart-beating donation. British Journal of Anaesthesia 2005; 95: 592-95.

Reason for Exclusion: general background

Robinette, MA Organ donation: Resource requirements and consent for donation. Anesthesiology Clinics of North America 1994; 12: 635-42.

Reason for Exclusion: general background

Rocheleau, CA Increasing family consent for organ donation: Findings and challenges. Progress in Transplantation 2001; 11: 194-200.

Reason for Exclusion: literature search

Rodrigue, JR, Cornell, DL, Howard, RJ Attitudes toward financial incentives, donor authorization, and presumed consent among next-of-kin who consented vs. refused organ donation. Transplantation 2006; 81: 1249-56.

Reason for Exclusion: practices looked at are not used in UK

Roza, BA, Pestana, JO, Barbosa, SF, Schirmer, J Organ donation procedures: an epidemiological study. Progress in transplantation (Aliso Viejo, Calif ) 2010; 20: 88-95.

Reason for Exclusion: looks at association between funeral aid and donation

Roza, BA, Pestana, JO, Barbosa, SF, Schirmer, J Organ donation procedures: an epidemiological study. Progress in Transplantation 2010; 20: 88-95.

Reason for Exclusion: looks at association between funeral aid and donation and duplicate

Santiago, C, Gomez, P Asking for the family consent: analysis and refusals. Transplantation Proceedings 1997; 29: 1629-30.

Reason for Exclusion: comment on a study

Saunders, B Normative consent and opt-out organ donation. Journal of Medical Ethics 2010; 36: 84-87.

Reason for Exclusion: general background

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 47 of 202

Shafer, TJ Improving relatives' consent to organ donation. BMJ 2009; 338: 1023.

Reason for Exclusion: literature search

Shaheen, FA, Souqiyyeh, MZ, Huraib, S, al-Khader, A, Attar, MB, Ibrahim, SM, Paul, TT, Babiker, MA, al-Swailem, AR The causes of family refusal to consent for organ donation from a brain-death relative in Saudi Arabia. Transplantation Proceedings 1996; 28: 387.

Reason for Exclusion: results incomplete and causes of refusal to consent not mentioned

Shaheen, FA, al-Khader, A, Souqiyyeh, MZ, Attar, MB, Tayab, A, Kurpad, RP, al-Swailem, AR Medical causes of failure to obtain consent for organ retrieval from brain-dead donors. Transplantation Proceedings 1996; 28: 167-68.

Reason for Exclusion: looking at medical causes of failure to obtain consent

Sharma, K Organ donation: The patients' views [3]. Palliative Medicine 1998; 12: 302-3.

Reason for Exclusion: not a study

Sheach Leith, VM Consent and nothing but consent? The organ retention scandal. Sociology of Health & Illness 2007; 29: 1023-42.

Reason for Exclusion: general background

Sills, P, Bair, HA, Gates, L, Janczyk, RJ Donation after cardiac death: lessons learned. Journal of Trauma Nursing 2007; 14: 47-50.

Reason for Exclusion: general background

Singh, P, Kumar, A, Sharma, RK Factors influencing refusal by relatives of brain-dead patients to give consent for organ donation: experience at a transplant centre. Journal of the Indian Medical Association 7 A.D.; 102: 630.

Reason for Exclusion: British Library can't find it

Spital, A Consent for organ donation: Time for a change. Clinical Transplantation 1993; 7: 525-28.

Reason for Exclusion: general background

Spital, A Consent for organ donation: today and tomorrow. Seminars in Dialysis 1993; 6: 264-67.

Reason for Exclusion: not a study

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 48 of 202

Spital, A Obtaining consent for organ donation: What are our options? Bailliere's Best Practice in Clinical Anaesthesiology 1999; 13: 179-93.

Reason for Exclusion: general background

Spital, A, Taylor, JS Reconsidering the consent requirement for organ recovery after death. Transplantation 2008; 86: 1632-33.

Reason for Exclusion: not a study

Starzl, TE Implied consent for cadaveric organ donation. JAMA 19 A.D.; 251: 1592-30. Reason for Exclusion: not a study

Tavakoli, SA, Shabanzadeh, AP, Arjmand, B, Aghayan, SH, Nozary, HB, Emami Razavi, SH, Bahrami, NH Comparative study of depression and consent among brain death families in donor and nondonor groups from March 2001 to December 2002 in Tehran. Transplantation Proceedings 2008; 40: 3299-302.

Reason for Exclusion: looking at association between depression and organ donation

Thayyil, S, Robertson, NJ, Scales, A, Weber, MA, Jacques, TS, Sebire, NJ, Taylor, AM, MaRIAS (Magnetic Resonance Imaging Autopsy Study) Collaborative Group Prospective parental consent for autopsy research following sudden unexpected childhood deaths: a successful model. Archives of Disease in Childhood 2009; 94: 354-58.

Reason for Exclusion: looking at consent for autopsy research purposes

Valapour, M Donation after cardiac death: consent is the issue, not death. Journal of Clinical Ethics 2006; 17: 137-38.

Reason for Exclusion: not a study

Webster, PA, Markham, L Pediatric organ donation: a national survey examining consent rates and characteristics of donor hospitals. Pediatric Critical Care Medicine 2009; 10: 500-504.

Reason for Exclusion: looking at relationship between identification and consent rates and no reasons stated for low consent rates

Wendler, D, Dickert, N The consent process for cadaveric organ procurement: how does it work? How can it be improved? JAMA 2001; 285: 329-33.

Reason for Exclusion: doesn’t describe the consent process or factors influencing them

West, R, Burr, G Why families deny consent to organ donation. Australian Critical Care 2002; 15: 27-32.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 49 of 202

Reason for Exclusion: literature search

Wicclair, MR Informed consent and research involving the newly dead. Kennedy Institute of Ethics Journal 2002; 12: 351-72.

Reason for Exclusion: general background

Wilkinson, TM Individual and family consent to organ and tissue donation: is the current position coherent?. [Review] [16 refs]. Journal of Medical Ethics 2005; 31: 587-90.

Reason for Exclusion: general background

Wilkinson, TM Parental consent and the use of dead children's bodies. Kennedy Institute of Ethics Journal 2001; 11: 337-58.

Reason for Exclusion: general background

Williams, MA, Lipsett, PA, Rushton, CH, Grochowski, EC, Berkowitz, ID, Mann, SL, Shatzer, JH, Short, MP, Genel, M, Council on Scientific Affairs, AMA The physician's role in discussing organ donation with families. [Review] [39 refs]. Critical Care Medicine 2003; 31: 1568-73.

Reason for Exclusion: general background

Review question 3 Aldridge, A, Guy, BS Deal breakers in the organ donation request process. Health Marketing Quarterly 2008; 23: 17-31.

Reason for Exclusion: general background

Arnold, RM, Youngner, SJ Time is of the essence: the pressing need for comprehensive non-heart-beating cadaveric donation policies. Transplantation Proceedings 2917; 27: 2913-17.

Reason for Exclusion: general background

Bell, MD Non-heartbeating organ donation: clinical process and fundamental issues. British Journal of Anaesthesia 2005; 94: 474-78.

Reason for Exclusion: looking at entire donation process rather than timing for consent

Bernat, JL The boundaries of organ donation after circulatory death. New England Journal of Medicine 2008; 359: 669-71.

Reason for Exclusion: not a study

Boucek, MM, Mashburn, C, Dunn, SM, Frizell, R, Edwards, L, Pietra, B, Campbell, D, Denver Children's Pediatric Heart Transplant Team Pediatric Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 50 of 202

heart transplantation after declaration of cardiocirculatory death. New England Journal of Medicine 2008; 359: 709-14.

Reason for Exclusion: looking at success of heart transplantation in children

Bousso, RS The family decision-making process concerning consent for donating their child's organs: a substantive theory [Portuguese]. Texto & Contexto Enfermagem 2008; 17: 45-55.

Reason for Exclusion: not in English

Brown, CV, Foulkrod, KH, Dworaczyk, S, Thompson, K, Elliot, E, Cooper, H, Coopwood, B Barriers to obtaining family consent for potential organ donors. Journal of Trauma-Injury Infection & Critical Care 2010; 68: 447-51.

Reason for Exclusion: for q2

Caillouet-O'Neal, C, Booker, QG Converting family advocates to level 1 recovery coordinators. Transplantation Proceedings 2008; 40: 1041-43.

Reason for Exclusion: for q2

Chapman, JR, Hibberd, AD, McCosker, C, Thompson, JF, Ross, W, Mahony, J, Byth, P, MacDonald, GJ Obtaining consent for organ donation in nine NSW metropolitan hospitals. Anaesthesia & Intensive Care 1995; 23: 81-87.

Reason for Exclusion: for q2

Chatterjee, SN, Payne, JE, Berne, TV Difficulties in obtaining kidneys from potential postmortem donors. JAMA 1975; 232: 822-24.

Reason for Exclusion: looking at obtaining kidneys only from donors

Cohen, MC, Blakey, S, Donn, T, McGovern, S, Parry, L An audit of parents'/guardians' wishes recorded after coronial autopsies in cases of sudden unexpected death in infancy: issues raised and future directions. Medicine, Science & the Law 2009; 49: 179-84.

Reason for Exclusion: looking at wishes recorded after autopsy and not donation

De Cabo, FM, Cabrer, C, Paredes, D, Navarro, A, Trias, E, Manyalich, M Timing comparison of donation process after the New Real decreto of transplantation in Spain. Transplantation Proceedings 2002; 34: 18.

Reason for Exclusion: looking at effects of new criteria to diagnose BSD and transplantation

De, WJ, Stirton, L Advance commitment: an alternative approach to the family veto problem in organ procurement. Journal of Medical Ethics 2010; 36: 180- 184.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 51 of 202

Reason for Exclusion: general background

DeVita, MA, Snyder, JV, Arnold, RM, Siminoff, LA Observations of withdrawal of life-sustaining treatment from patients who became non-heart-beating organ donors. Critical Care Medicine 2000; 28: 1709-12.

Reason for Exclusion: looking at observations made to confirm brain death

Douglas, S Factors affecting cadaveric organ donation: a national survey of organ procurement coordinators. Journal of Transplant Coordination 1994; 4: 96-103.

Reason for Exclusion: for q2

Durall, AL, Laussen, PC, Randolph, AG Potential for donation after cardiac death in a children's hospital. Pediatrics 2007; 119: e219-eNaN.

Reason for Exclusion: looking at identification of potential kidney donors

Haddow, G Donor and nondonor families' accounts of communication and relations with healthcare professionals. Progress in Transplantation 2004; 14: 41-48.

Reason for Exclusion: for q2

Haire, MC, Hinchliff, JP Donation of heart valve tissue: seeking consent and meeting the needs of donor families. Medical Journal of Australia 1996; 164: 28-31.

Reason for Exclusion: looking at tissue donation and nor organ donation

Hassan, TB, Joshi, M, Quinton, DN, Elwell, R, Baines, J, Bell, PR Role of the accident and emergency department in the non-heart-beating donor programme in Leicester. Journal of Accident & Emergency Medicine 1996; 13: 321-24.

Reason for Exclusion: looking at effect of NHBD programme at identification of potential kidney donors

Helms, AK, Torbey, MT, Hacein-Bey, L, Chyba, C, Varelas, PN Standardized protocols increase organ and tissue donation rates in the neurocritical care unit. Neurology 2004; 63: 1955-57.

Reason for Exclusion: looking at identification rather than timing

Howard, DH, Siminoff, LA, McBride, V, Lin, M Does quality improvement work? Evaluation of the organ donation breakthrough collaborative. Health Services Research 2007; 42: 2160-2173.

Reason for Exclusion: for q2

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 52 of 202

Lawlor, M, Kerridge, I Registering wishes about organ and tissue donation: Personal discussion during licence renewal may be superior to online registration. Internal Medicine Journal 2009; 39: 835-37.

Reason for Exclusion: general background

Marks, WH, Wagner, D, Pearson, TC, Orlowski, JP, Nelson, PW, McGowan, JJ, Guidinger, MK, Burdick, J Organ donation and utilization, 1995-2004: Entering the collaborative era. American Journal of Transplantation 2006; 6: 1101-10.

Reason for Exclusion: general background

Matesanz, R, Dominguez-Gil, B Strategies to optimize deceased organ donation. Transplantation Reviews 2007; 21: 177-88.

Reason for Exclusion: general background

Montefusco, CM, Levine, S, Goldsmith, J, Veith, FJ Obtaining consent for organ donation. Hospital Physician 1985; 21: 46-50.

Reason for Exclusion: general background

Neades, BL Organ donation in A&E: the legal and ethical implications for the A&E nurse. [Review] [76 refs]. Accident & Emergency Nursing 2001; 9: 109- 22.

Reason for Exclusion: general background

Randhawa, G Specialist nurse training programme: dealing with asking for organ donation. Journal of Advanced Nursing 1998; 28: 405-8.

Reason for Exclusion: for q4

Reich, DJ, Mulligan, DC, Abt, PL, Pruett, TL, Abecassis, MMI, D'Alessandro, A, Pomfret, EA, Freeman, RB, Markmann, JF, Hanto, DW, Matas, AJ, Roberts, JP, Merion, RM, Klintmalm, GBG ASTS recommended practice guidelines for controlled donation after cardiac death organ procurement and transplantation. American Journal of Transplantation 2009; 9: 2004-11.

Reason for Exclusion: general background

Robinette, MA Organ donation: Resource requirements and consent for donation. Anesthesiology Clinics of North America 1994; 12: 635-42.

Reason for Exclusion: general background

Rodrigue, JR, Cornell, DL, Howard, RJ The instability of organ donation decisions by next-of-kin and factors that predict it. American Journal of Transplantation 2008; 8: 2661-67.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 53 of 202

Reason for Exclusion: for q2

Shafer, TJ, Ehrle, RN, Davis, KD, Durand, RE, Holtzman, SM, Van Buren, CT, Crafts, NJ, Decker, PJ Increasing organ recovery from level I trauma centers: the in-house coordinator intervention. Progress in Transplantation 2004; 14: 250-263.

Reason for Exclusion: looking at identification of donors

Shih, FJ, Lai, MK, Lin, MH, Lin, HY, Tsao, CI, Duh, BR, Chu, SH The dilemma of "to-be or not-to-be": needs and expectations of the Taiwanese cadaveric organ donor families during the pre-donation transition. Social Science & Medicine 2001; 53: 693-706.

Reason for Exclusion: for q2

Siminoff, LA, Nelson, KA The accuracy of hospital reports of organ donation eligibility, requests, and consent: a cross-validation study. Joint Commission Journal on Quality Improvement 1999; 25: 129-36.

Reason for Exclusion: looking at identification of potential donors

Simpkin, AL, Robertson, LC, Barber, VS, Young, JD Modifiable factors influencing relatives' decision to offer organ donation: systematic review. [Review] [7 refs]. BMJ 2009; 338: b991.

Reason for Exclusion: literature search

Siminoff, LA Withdrawal of treatment and organ donation. Critical Care Nursing Clinics of North America 1997; 9: 85-96.

Reason for Exclusion: British Library can't find it

Sotillo, E, Montoya, E, Martinez, V, Paz, G, Armas, A, Liscano, C, Hernandez, G, Perez, M, Andrade, A, Villasmil, N, Mollegas, L, Hernandez, E, Milanes, CL, Rivas, P Identification of variables that influence brain-dead donors' family groups regarding refusal. Transplantation Proceedings 2009; 41: 3466-70.

Reason for Exclusion: for q2

Spital, A Consent for organ donation: Time for a change. Clinical Transplantation 1993; 7: 525-28.

Reason for Exclusion: general background

West, R, Burr, G Why families deny consent to organ donation. Australian Critical Care 2002; 15: 27-32.

Reason for Exclusion: literature search

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 54 of 202

Review question 4 How to manage vital-organ donors. Nursing 1999; 29: 32cc11-13.

Reason for Exclusion: British Library can't find it

Abdo, A, Ugarte, JC, Castellanos, R, Gonzalez, L, Lopez, O, Hernandez, JC, Valdivia, J, Almora, E, Suarez, O, Diaz, J, Collera, S, Enamorado, A, Vazquez, A, Benite, P, Dominguez, J, Wilford, M, Falcon, J The transplantation donation process in the Centro de Investigaciones Medico Quirurgicas of Cuba: 1999-2002. Transplantation Proceedings 2003; 35: 1636-37.

Reason for Exclusion: not looking at specific role of SNOD in the organ donation care pathway

Arbour, R Clinical management of the organ donor. [Review] [86 refs]. AACN Clinical Issues 600; 16: 551-80.

Reason for Exclusion: general background

Austen, D Establishing a Queensland wide network for the holistic approach to organ donation and transplantation: the Link Nurse phenomenon. Transplant Journal of Australasia 2005; 14: 10-15.

Reason for Exclusion: British Library can't find it

Bodenham, A, Park, GR Care of the multiple organ donor. [Review] [56 refs]. Intensive Care Medicine 1989; 15: 340-348.

Reason for Exclusion: general background

Brody, B What can and cannot be learned from the Pittsburgh experience. Critical Care Medicine 2000; 28: 2134-35.

Reason for Exclusion: general background

Brown, ME Clinical management of the organ donor. [Review] [25 refs]. DCCN - Dimensions of Critical Care Nursing 1989; 8: 134-41.

Reason for Exclusion: narrative review

Cohen, J, Ami, SB, Ashkenazi, T, Singer, P Attitude of health care professionals to brain death: influence on the organ donation process. Clinical Transplantation 2008; 22: 211-15.

Reason for Exclusion: looking at attitudes of HCPs towards organ donation

D'Alessandro, AM Current results of an organ procurement organization effort to increase utilization of donors after cardiac death. Transplantation 2006; 81: 15.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 55 of 202

Reason for Exclusion: expert opinion

D'Alessandro, AM, Peltier, JW, Phelps, JE Increasing organ donations after cardiac death by increasing DCD support among health care professionals: A case report. American Journal of Transplantation 2008; 8: 897-904.

Reason for Exclusion: looking at increasing knowledge and providing support to HCPs to increase DCD

D'Alessandro, AM, Peltier, JW, Phelps, JE Understanding the antecedents of the acceptance of donation after cardiac death by healthcare professionals. Critical Care Medicine 2008; 36: 1075-81.

Reason for Exclusion: looks at overall barriers with DCD donation

Darby, JM, Stein, K, Grenvik, A, Stuart, SA Approach to management of the heartbeating 'brain dead' organ donor. [Review] [71 refs]. JAMA 1989; 261: 2222-28.

Reason for Exclusion: general background

Davis, FD Coordination of cardiac transplantation: patient processing and donor organ procurement. Circulation 1987; 75: 29-39.

Reason for Exclusion: general background

Delmonico, FL, Reese, JC Organ donor issues for the intensive care physician. Journal of Intensive Care Medicine 1998; 13: 269-79.

Reason for Exclusion: general background

DeVeaux, TE Non-heart-beating organ donation: Issues and ethics for the critical care nurse. Journal of Vascular Nursing 2006; 24: 17-21.

Reason for Exclusion: general background on ethics for the critical care nurse

Dictus, C, Vienenkoetter, B, Esmaeilzadeh, M, Unterberg, A, Ahmadi, R Critical care management of potential organ donors: our current standard. [Review] [81 refs]. Clinical Transplantation 2009; 23: Suppl-9.

Reason for Exclusion: general background

DuBois, JM, DeVita, M Donation after cardiac death in the United States: How to move forward. Critical Care Medicine 2006; 34: 3045-47.

Reason for Exclusion: general background

Edwards, J, Mulvania, P, Robertson, V, George, G, Hasz, R, Nathan, H, D'Alessandro, A Maximizing organ donation opportunities through donation after cardiac death. Critical Care Nurse 2006; 26: 101-16.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 56 of 202

Reason for Exclusion: general background

Fidler, SA Implementing donation after cardiac death protocols. Journal of health & life sciences law 2008; 2: 123, 125-23, 149.

Reason for Exclusion: British Library can’t find it

Filipponi, F, De, SP, Rossi, E The Tuscany model of a regional transplantation service authority: Organizzazione Toscana Trapianti. Transplantation Proceedings 2007; 39: 2953-60.

Reason for Exclusion: implementation of a regional network

Follette, D, Rudich, S, Bonacci, C, Allen, R, Hoso, A, Albertson, T Importance of an aggressive multidisciplinary management approach to optimize lung donor procurement. Transplantation Proceedings 1999; 31: 169-70.

Reason for Exclusion: looks at procurement strategies for obtaining lungs as organs

Frontera, JA How i manage the adult potential organ donor: Donation after cardiac death (Part 2). Neurocritical Care 2010; 12: 111-16.

Reason for Exclusion: expert opinion

Frontera, JA, Kalb, T How I manage the adult potential organ donor: donation after neurological death (part 1). Neurocritical Care 2010; 12: 103-10.

Reason for Exclusion: expert opinion

Holmquist, M, Chabalewski, F, Blount, T, Edwards, C, McBride, V, Pietroski, R A critical pathway: guiding care for organ donors. [Review] [36 refs]. Critical Care Nurse 1999; 19: 84-98.

Reason for Exclusion: general background

Holmquist, M Organ donor Care MAP: a multidisciplinary approach. [Review] [4 refs]. Journal of Transplant Coordination 1996; 6: 101-4.

Reason for Exclusion: looking at role of ICU nurses after consent has been obtained

House, MA, Durham, J, Joyner, J An OPO's experience with a donor family support program. Journal of Transplant Coordination 1993; 3: 36-38.

Reason for Exclusion: looking at effects of establishing family support programs

Matesanz, R, Miranda, B, Felipe, C Organ procurement and renal transplants in Spain: the impact of transplant coordination. Spanish National Transplant

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 57 of 202

Organization (ONT). Nephrology Dialysis Transplantation 479; 9: 475-78.

Reason for Exclusion: description of a Spanish model but not evaluation

Meyer, K, Bjork, IT Change of focus: from intensive care towards organ donation. Transplant International 2008; 21: 133-39.

Reason for Exclusion: looks at educational and other needs of nurses in the OD process

Noah, P, Morgan, S Organ/tissue donation request: a multidisciplinary approach. Critical Care Nursing Quarterly 1999; 22: 30-38.

Reason for Exclusion: general background

Petro, JA, Tack, CM, Groh, J Up close & clinical. A critical pathway for organ donation: one possible solution to a crucial need. Nursing Spectrum -- Philadelphia Tri -- State Edition 1997; 6: 10-12.

Reason for Exclusion: British Library can't find it

Powner, DJ, Darby, JM, Kellum, JA Proposed treatment guidelines for donor care. Progress in Transplantation 2004; 14: 16-26.

Reason for Exclusion: a guideline

Rayburn, AB A multipronged approach to addressing the organ shortage. Journal of Cardiovascular Nursing 2005; 20: Suppl-21.

Reason for Exclusion: general background

Rosendale, JD, Chabalewski, FL, McBride, MA, Garrity, ER, Rosengard, BR, Delmonico, FL, Kauffman, HM Increased transplanted organs from the use of a standardized donor management protocol. American Journal of Transplantation 2002; 2: 761-68.

Reason for Exclusion: looks at the effects of implementing a new process to increase identification of donors and not looking at role of SNOD in the care pathway

Whiting, JF, Delmonico, F, Morrissey, P, Basadonna, G, Johnson, S, Lewis, WD, Rohrer, R, O'Connor, K, Bradley, J, Lovewell, TD, Lipkowitz, G Clinical results of an organ procurement organization effort to increase utilization of donors after cardiac death. Transplantation 2006; 81: 1368-71.

Reason for Exclusion: the paper looks at increasing identification rates rather than the role of SNOD in the care pathway

Wight, C, Cohen, B, Roels, L, Miranda, B Donor action: A quality assurance program for intensive care units that increases organ donation. Journal of Intensive Care Medicine 2000; 15: 104-14.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 58 of 202

Reason for Exclusion: not looking at the specific role of SNOD in the OD care pathway

Zavotsky, KE, Tamburri, LM A Case in Successful Organ Donation: Emergency Department Nurses Do Make a Difference. Journal of Emergency Nursing 2007; 33: 235-41.

Reason for Exclusion: general background

Review question 5 As noted above, evidence from other questions was used to inform recommendations on skills and competencies needed. There are therefore no excluded studies for this question.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 59 of 202

Appendix B References of all included studies Review question 1

Total number of studies retrieved from searches = 1523

Selection based on title and Excluded = 1433 abstract = 90 (full papers ordered)

Selection based on full papers = 14 Excluded = 76

Total number of studies included = 14 13 studies part of evidence 1 study as supporting evidence

Review question 2

Total number of studies retrieved from searches = 1298

Selection based on title and Excluded = 1165 abstract = 133 (full papers ordered)

Selection based on full papers = 38 Excluded = 95

Total number of studies included = 38 5 studies duplicate

Review question 3

Total number of studies retrieved from searches = 254

Selection based on title and Excluded = 206 abstract = 48 (full papers ordered)

Selection based on full papers = 10 Excluded =38

Total number of studies included = 10

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 60 of 202

Review question 4

Total number of studies retrieved from searches = 390

Selection based on title and Excluded = 350 abstract = 40 (full papers ordered)

Selection based on full papers = 4 Excluded =36

Total number of studies included = 4

Review question 5

Although searches were undertaken for this question, the technical team and the GDG considered that evidence already reviewed and included for other questions would adequately inform evidence based recommendations on the skills and competencies needed by healthcare professionals. For example, where a lack of knowledge or skills were identified for healthcare professionals as part of review question 2, a recommendation was made that healthcare professionals should have those skills and knowledge in order to deliver the other recommendations made in the guideline.

Included studies

Review question 1

Aubrey, P, Arber, S, Tyler, M The organ donor crisis: the missed organ donor potential from the accident and emergency departments. Transplantation Proceedings 2008; 40: 1008-11.

Bair, HA, Sills, P, Schumacher, K, Bendick, PJ, Janczyk, RJ, Howells, GA Improved organ procurement through implementation of evidence-based practice. Journal of Trauma Nursing 2006; 13: 183-85. Ref ID: 96

Burris, GW, Jacobs, AJ A continuous quality improvement process to increase organ and tissue donation. Journal of Transplant Coordination 1996; 6: 88- 92. Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 61 of 202

Dickerson, J, Valadka, AB, Levert, T, Davis, K, Kurian, M, Robertson, CS Organ donation rates in a neurosurgical intensive care unit. Journal of Neurosurgery 2002; 97: 811-14.

Gabel, H, Edstrom, B Number of potential cadaveric donors: reasons for nonprocurement and suggestions for improvement. Transplantation Proceedings 1993; 25: 3136.

Gallagher, C Religious attitudes regarding organ donation. Journal of Transplant Coordination 1996; 6: 186-91.

Gortmaker, SL, Beasley, CL, Brigham, LE, Franz, HG, Garrison, RN, Lucas, BA, Patterson, RH, Sobol, AM, Grenvik, NA, Evanisko, MJ Organ donor potential and performance: size and nature of the organ donor shortfall. Critical Care Medicine 1996; 24: 432-39.

Graham, JM, Sabeta, ME, Cooke, JT, Berg, ER, Osten, WM A system's approach to improve organ donation. Progress in Transplantation 2009; 19: 216-20.

Higashigawa, KH, Carroll, C, Wong, LL Organ procurement 1999-2000: how is Hawaii doing? Hawaii Medical Journal 2001; 60: 314-17.

Higashigawa, KH, Carroll, C, Wong, LL, Wong, LM Organ donation in Hawaii: impact of the final rule. Clinical Transplantation 2002; 16: 180-184.

Madsen, M, Bogh, L Estimating the organ donor potential in Denmark: a prospective analysis of deaths in intensive care units in northern Denmark. Transplantation Proceedings 2005; 37: 3258-59.

Moller, C, Welin, A, Henriksson, BA, Rydvall, A, Karud, K, Nolin, T, Brorson, I, Nilsson, L, Lundberg, D, Swedish Council for Organ and Tissue Donation National survey of potential heart beating solid organ donors in Sweden. Transplantation Proceedings 2009; 41: 729-31.

Molzahn, AE Knowledge and attitudes of physicians regarding organ donation. Annals of the Royal College of Physicians & Surgeons of Canada 1997; 30: 29-32.

Murphy, F, Cochran, D, Thornton, S Impact of a Bereavement and Donation Service incorporating mandatory 'required referral' on organ donation rates: a model for the implementation of the Organ Donation Taskforce's recommendations. Anaesthesia 2009; 64: 822-28.

Opdam, HI, Silvester, W Identifying the potential organ donor: an audit of hospital deaths. Intensive Care Medicine 2004; 30: 1390-1397.

Pearson, IY, Zurynski, Y A survey of personal and professional attitudes of intensivists to organ donation and transplantation. Anaesthesia & Intensive Care 1995; 23: 68-74.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 62 of 202

Petersen, P, Fischer-Frohlich, CL, Konigsrainer, A, Lauchart, W Detection of potential organ donors: 2-year analysis of deaths at a German university hospital. Transplantation Proceedings 2009; 41: 2053-54.Ref ID: 56

Ploeg, RJ, Niesing, J, Sieber-Rasch, MH, Willems, L, Kranenburg, K, Geertsma, A Shortage of donation despite an adequate number of donors: a professional attitude? Transplantation 2003; 76: 948-55.

Pugliese, MR, Degli, ED, Dormi, A, Venturoli, N, Mazzetti, GP, Buscaroli, A, Petropulacos, K, Nanni, CA, Ridolfi, L Improving donor identification with the Donor Action programme. Transplant International 2003; 16: 21-25.

Robertson, VM, George, GD, Gedrich, PS, Hasz, RD, Kochik, RA, Nathan, HM Concentrated professional education to implement routine referral legislation increases organ donation. Transplantation Proceedings 1998; 30: 214-16.

Shafer, TJ, Durand, R, Hueneke, MJ, Wolff, WS, Davis, KD, Ehrle, RN, Van Buren, CT, Orlowski, JP, Reyes, DH, Gruenenfelder, RT, White, CK Texas non-donor-hospital project: a program to increase organ donation in community and rural hospitals. Journal of Transplant Coordination 1998; 8: 146-52.

Shafer, TJ, Ehrle, RN, Davis, KD, Durand, RE, Holtzman, SM, Van Buren, CT, Crafts, NJ, Decker, PJ Increasing organ recovery from level I trauma centers: the in-house coordinator intervention. Progress in Transplantation 2004; 14: 250-263.

Shafer, TJ, Wagner, D, Chessare, J, Schall, MW, McBride, V, Zampiello, FA, Perdue, J, O'Connor, K, Lin, MJ, Burdick, J US organ donation breakthrough collaborative increases organ donation. Critical Care Nursing Quarterly 2008; 31: 190-210.

Thompson, JF, McCosker, CJ, Hibberd, AD, Chapman, JR, Compton, JS, Mahony, JF, Mohacsi, PJ, Macdonald, GJ, Spratt, PM The identification of potential cadaveric organ donors. Anaesthesia & Intensive Care 1995; 23: 75-80.

Van, GF, Van, HD, de, RJ, Monbaliu, D, Aerts, R, Coosemans, W, Daenen, W, Pirenne, J Implementation of an intervention plan designed to optimize donor referral in a donor hospital network. Progress in Transplantation 2006; 16: 46-51.

Wood, DM, Dargan, PI, Jones, AL Poisoned patients as potential organ donors: Postal survey of transplant centres and intensive care units. Critical Care 2003; 7: 147-54.

Review question 2 ACRE, TC Effect of "collaborative requesting" on consent rate for organ donation: randomised controlled trial (ACRE trial). BMJ 2009; 339: b3911.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 63 of 202

Bellali, T, Papazoglou, I, Papadatou, D Empirically based recommendations to support parents facing the dilemma of paediatric cadaver organ donation. Intensive & Critical Care Nursing 2007; 23: 216-25.

Bellali, T, Papadatou, D Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Death Studies 2006; 30: 883-917.

Bellali, T, Papadatou, D The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Social Science and Medicine 2007; 64: 439-50.

Brown, CV, Foulkrod, KH, Dworaczyk, S, Thompson, K, Elliot, E, Cooper, H, Coopwood, B Barriers to obtaining family consent for potential organ donors. Journal of Trauma-Injury Infection & Critical Care 2010; 68: 447-51.

Brown, CVR, Foulkrod, KH, Dworaczyk, S, Thompson, K, Elliot, E, Cooper, H, Coopwood, B Barriers to obtaining family consent for potential organ donors. Journal of Trauma - Injury, Infection and Critical Care 2010; 68: 447-51.

Burroughs, TE, Hong, BA, Kappel, DF, Freedman, BK The stability of family decisions to consent or refuse organ donation: would you do it again? Psychosomatic Medicine 1998; 60: 156-62.

Caballero, F, Lopez-Navidad, A, Leal, J, Garcia-Sousa, S, Soriano, JA, Domingo, P The cultural level of cadaveric potential organ donor relatives determines the rate of consent for donation. Transplantation Proceedings 1999; 31: 2601.

Cleiren, MP, Van Zoelen, AA Post-mortem organ donation and grief: a study of consent, refusal and well-being in bereavement. Death Studies 2002; 26: 837-49.

Douglas, S Factors affecting cadaveric organ donation: a national survey of organ procurement coordinators. Journal of Transplant Coordination 1994; 4: 96-103.

Douglass, GE, Daly, M Donor families' experience of organ donation. Anaesthesia and Intensive Care 1995; 23: 96-98.

Frauman, AC, Miles, MS Parental willingness to donate the organs of a child. Anna Journal 1987;

14: 401-4.

Frutos, MA, Ruiz, P, Requena, MV, Daga, D Family refusal in organ donation: Analysis of three patterns. Transplantation Proceedings 2002; 34: 2513-14.

Haddow, G Donor and nondonor families' accounts of communication and relations with healthcare professionals. Progress in Transplantation 2004; 14: 41-48.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 64 of 202

Jacoby, LH, Breitkopf, CR, Pease, EA A qualitative examination of the needs of families faced with the option of organ donation. DCCN - Dimensions of Critical Care Nursing 2005; 24: 183-89.

La, SF, Sedda, L, Pizzi, C, Verlato, R, Boselli, L, Candiani, A, Chiaranda, M, Frova, G, Gorgerino, F, Gravame, V, Mapelli, A, Martini, C, Pappalettera, M, Seveso, M, Sironi, PG Donor families' attitude toward organ donation. Transplantation Proceedings 1993; 25: 1699-701.

La, SF, Sedda, L, Pizzi, C, Verlato, R, Boselli, L, Candiani, A, Chiaranda, M, Frova, G, Gorgerino, F, Gravame, V, Mapelli, A, Martini, C, Pappalettera, M, Seveso, M, Sironi, PG Donor families' attitude toward organ donation. Transplantation Proceedings 1993; 25: 1699-701.

Martinez, JM, Lopez, JS, Martin, A, Martin, MJ, Scandroglio, B, Martin, JM Organ donation and family decision-making within the Spanish donation system. Social Science & Medicine 2001; 53: 405-21.

Niles, PA, Mattice, BJ The timing factor in the consent process. Journal of Transplant Coordination 1996; 6: 84-87.

Noury, D, Jacob, F, Pottecher, T, Boulvard, A, Pain, L Information on relatives of organ and tissue donors. A multicenter regional study: factors for consent or refusal. Transplantation Proceedings 1996; 28: 135-36.

Pearson, IY, Bazeley, P, Spencer-Plane, T, Chapman, JR, Robertson, P A survey of families of brain dead patients: Their experiences, attitudes to organ donation and transplantation. Anaesthesia and Intensive Care 1995; 23: 88- 95.

Pietz, CA, Mayes, T, Naclerio, A, Taylor, R Pediatric organ transplantation and the hispanic population: approaching families and obtaining their consent. Transplantation Proceedings 2004; 36: 1237-40.

Pike, RE, Kahn, D, Jacobson, JE Demographic factors influencing consent for cadaver organ donation. South African Medical Journal 1991; Suid- Afrikaanse: 264-67.

Rodrigue, JR, Cornell, DL, Howard, RJ The instability of organ donation decisions by next-of-kin and factors that predict it. American Journal of Transplantation 2008; 8: 2661-67.

Sanner, MA Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Journal of Critical Care 2007; 22: 296-304.

Shaheen, FA, al-Khader, A, Souqiyyeh, MZ, Attar, MB, Ibrahim, S, Paul, TT, al-Swailem, AR Trend of consents for donation by relatives of cadaveric donors in the Kingdom of Saudi Arabia. Transplantation Proceedings 1996; 28: 381.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 65 of 202

Siminoff, LA, Lawrence, RH, Zhang, A Decoupling: what is it and does it really help increase consent to organ donation? Progress in Transplantation 2002; 12: 52-60.

Siminoff, LA, Gordon, N, Hewlett, J, Arnold, RM Factors influencing families' consent for donation of solid organs for transplantation. JAMA 2001; 286: 71- 77.

Siminoff, LA, Gordon, N, Hewlett, J, Arnold, RM Factors influencing families' consent for donation of solid organs for transplantation. Journal of the American Medical Association 2001; 286: 71-77.

Siminoff, LA, Lawrence, RH Knowing patients' preferences about organ donation: does it make a difference? Journal of Trauma-Injury Infection & Critical Care 2002; 53: 754-60.

Siminoff, LA, Arnold, RM, Hewlett, J The process of organ donation and its effect on consent. Clinical Transplantation 2001; 15: 39-47.

Siminoff, LA, Arnold, RM, Hewlett, J The process of organ donation and its effect on consent. Clinical Transplantation 2001; 15: 39-47.

Sotillo, E, Montoya, E, Martinez, V, Paz, G, Armas, A, Liscano, C, Hernandez, G, Perez, M, Andrade, A, Villasmil, N, Mollegas, L, Hernandez, E, Milanes, CL, Rivas, P Identification of variables that influence brain-dead donors' family groups regarding refusal. Transplantation Proceedings 2009; 41: 3466-70.

Sque, M, Long, T, Payne, S, Allardyce, D Why relatives do not donate organs for transplants: 'sacrifice' or 'gift of life'? Journal of Advanced Nursing 2008; 61: 134-44.

Vane, DW, Sartorelli, KH, Reese, J Emotional considerations and attending involvement ameliorates organ donation in brain dead pediatric trauma victims. Journal of Trauma-Injury Infection & Critical Care 2001; 51: 329-31.

Weiss, AH, Fortinsky, RH, Laughlin, J, Lo, B, Adler, NE, Mudge, C, Dimand, RJ Parental consent for pediatric cadaveric organ donation. Transplantation Proceedings 1997; 29: 1896-901.

Yong, BH, Cheng, B, Ho, S Refusal of consent for organ donation: from survey to bedside. Transplantation Proceedings 2000; 32: 1563.

Young, D, Danbury, C, Barber, V, Collett, D, Jenkins, B, Morgan, K, Morgan, L, Poppitt, E, Richards, S, Edwards, S, Patel, S Effect of "collaborative requesting" on consent rate for organ donation: Randomised controlled trial (ACRE trial). BMJ 2009; 339: 899-901.

Review question 3 Bellali, T, Papadatou, D Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Death Studies 2006; 30: 883-917.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 66 of 202

Bellali, T, Papadatou, D The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Social Science and Medicine 2007; 64: 439-50.

Bellali, T, Papazoglou, I, Papadatou, D Empirically based recommendations to support parents facing the dilemma of paediatric cadaver organ donation. Intensive & Critical Care Nursing 2007; 23: 216-25.

Cutler, JA, David, SD, Kress, CJ, Stocks, LM, Lewino, DM, Fellows, GL, Messer, SS, Zavala, EY, Halasz, NA Increasing the availability of cadaveric organs for transplantation maximizing the consent rate. Transplantation 1993; 56: 225-28.

Haddow, G Donor and nondonor families' accounts of communication and relations with healthcare professionals. Progress in Transplantation 2004; 14: 41-48.

Jacoby, LH, Breitkopf, CR, Pease, EA A qualitative examination of the needs of families faced with the option of organ donation. DCCN - Dimensions of Critical Care Nursing 2005; 24: 183-89.

Niles, PA, Mattice, BJ The timing factor in the consent process. Journal of Transplant Coordination 1996; 6: 84-87.

Sanner, MA Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Journal of Critical Care 2007; 22: 296-304.

Siminoff, LA, Lawrence, RH, Zhang, A Decoupling: what is it and does it really help increase consent to organ donation? Progress in Transplantation 2002; 12: 52-60.

Vane, DW, Sartorelli, KH, Reese, J Emotional considerations and attending involvement ameliorates organ donation in brain dead pediatric trauma victims. Journal of Trauma-Injury Infection & Critical Care 2001; 51: 329-31.

Review question 4 Al-Sebayel, MI, Al-Enazi, AM, Al-Sofayan, MS, Al-Saghier, MI, Khalaf, HA, Kabbani, MA, Nafae, OM, Khuroo, SS Improving organ donation in Central Saudi Arabia. Saudi Medical Journal 2004; 25: 1366-68.

Roth, BJ, Sher, L, Murray, JA, Belzberg, H, Mateo, R, Heeran, A, Romero, J, Mone, T, Chan, L, Selby, R Cadaveric organ donor recruitment at Los Angeles County Hospital: improvement after formation of a structured clinical, educational and administrative service. Clinical Transplantation 2003; 17: Suppl-7.

Shafer, TJ, Ehrle, RN, Davis, KD, Durand, RE, Holtzman, SM, Van Buren, CT, Crafts, NJ, Decker, PJ Increasing organ recovery from level I trauma centers:

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 67 of 202

The in-house coordinator intervention. Progress in Transplantation 2004; 14: 250-263.

Shafer, TJ, Durand, R, Hueneke, MJ, Wolff, WS, Davis, KD, Ehrle, RN, Van Buren, CT, Orlowski, JP, Reyes, DH, Gruenenfelder, RT, White, CK Texas non-donor-hospital project: a program to increase organ donation in community and rural hospitals. Journal of Transplant Coordination 1998; 8: 146-52.

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Appendix C Full GRADE evidence profiles KEY: NS = not serious

S = serious

NA = not assessable or applicable

Review question 1: What structures and processes including timing for referral and criteria for consideration are appropriate and effective for identifying potential DBD and DCD donors? The characteristic of imprecision was not assessed for this question as the type of evidence included often did not allow any assessment of the preciseness of any summary estimate. GRADE profile 1: Structures and processes for identifying potential DBD and DCD donors

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 9 studies S NA S S Studies showed that one of the factors for low identification rates were that healthcare professionals missed Very low (a) (b) (c) identifying potential donors. 3 x Audit retrospective studies-[A], [P], [Ma] 1 x Audit report-[G&E] 1 x Medical records retrospective review-[G] 3 x Survey

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 69 of 202

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration questionnaires- [O], [W], [M] 1 x Audit prospective study- [T] 1 study S NA S S A study showed that there was an improvement in identification of potential donors in hospitals with a donor Very low (a) (b) (c) action programme implemented. 1 x Audit study- [Pu] 2 studies S NA S S Studies showed that a lack of organ donation protocol or knowledge of the referral process in emergency Very low (a) (b) (c) departments may be a cause for non identification of potential donors. 1 x Audit retrospective study-[A] 1 x Survey using a questionnaire- [Mo]

2 studies S NA S S Studies showed that health care professionals did not approach family members to make a decision about Very low (a) (b) (c) donation. 1 x Medical records retrospective reviews-[G] 1 x Survey questionnaire- [O] 1 study S NA S S A study showed that health care staff felt that families were too stressed to be approached for organ donation. Very low (a) (b) (c) 1 x Survey questionnaire- [Pe] 1 study S NA S S A study showed the lack of available contact details of the DTC in emergency departments as a factor for lack Very low (a) (b) (c) of identification of potential donors. 1 x Audit retrospective study-[A] 1 study S NA S S A study showed the following personnel should be part of the identification process in the emergency Very low (a) (b) (c) department:

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 70 of 202

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 x Audit retrospective study-[A] Hospital consultants- A&E, anaesthetists and neuro-surgeons Emergency trauma team A&E nursing and medical staff 1 study S NA S S A study showed that HM coroner’s involvement was seen as too complex, acting as a barrier cited by health Very low (a) (b) (c) care staff as to why patients may not be recognized as potential donors in the A&E department. 1 x Audit retrospective study-[A] 1 study S NA S S A study showed that lack of confidence and experience of A&E staff in offering the option of donation to Very low (a) (b) (c) acutely bereaved families acted as a barrier cited by health care staff as to why patients may not be 1 x Audit retrospective recognised as potential donors in the A&E department. study-[A] 2 studies S NA S S Studies showed that health care professionals perceived that a lack of resources and shortage of intensive Very low (a) (b) (c) care beds in the hospital may have contributed to non identification and referral. 1 x Audit retrospective study-[A] 1 x Survey questionnaire- [Pe] 1 study S NA S S A study showed the following factors which influenced the decision to discuss with families regarding organ Very low (a) (b) (c) donation: 1 x Structured questionnaire- [Pl] Number of potential organs in a particular donor Knowledge of contraindications by physician Cause of death with natural causes of death Sex of the physician, female physicians are more likely to ask than male colleagues. 2 studies S NA S S Studies showed that people from African-American origin and people with perceived cultural differences were Very low (a) (b) (c) less likely to donate and also health care professionals were less likely to approach them. 1 x Medical records retrospective review-[G] 1 x Survey questionnaire- [Pe]

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 study S NA S S A study showed that rates of organ donation were higher when the cause of death was a motor vehicle Very low (a) (b) (c) accident, a gunshot wound or stabbing, or other head trauma compared with cerebrovascular, asphyxiation, 1 x Medical records or cardiovascular events retrospective review-[G] 1 study S NA S S A study showed that threats to staff from family members acted as a barrier to identification of potential Very low (a) (b) (c) donors. 1 x Survey questionnaire- [Pe] 1 study S NA S S A study showed that healthcare staff experienced language difficulties in explaining to families about organ Very low (a) (b) (c) donation which acted as a barrier to identification of potential donors. 1 x Survey questionnaire- [Pe] 1 study S NA S S A study showed that healthcare staff felt that approaching families for organ donation was too emotionally Very low (a) (b) (c) demanding and acted as a barrier to identification of potential donors. 1 x Survey using a questionnaire- [Mo] 1 study S NA S S A study showed that healthcare professional’s fear of potential litigation was a factor for non identification and Very low (a) (b) (c) donation. 1 x Survey using a questionnaire- [Mo] 1 study S NA S S A study showed that healthcare professionals identified the following factors that acted as barriers for non Very low (a) (b) (c) identification of potential donors: 1 x Structured questionnaire- [Pl] Lack of time Did not think Difficult situation [A] = Aubrey et al. (2008) [G&E] = Gabel and Edstrom (1993) [P] = Petersen et al. (2009) [G] = Gortmaker et al. (1996) [O] = Opdham et al. (2004)

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[T] = Thompson et al. (1995) [W] = Wood et al. (2003) [M] = Moller et al. (2009) [Ma] = Madsen et al. (2006) [Pu] = Pugliese et al. (2003) [Mo] = Molzahn et al. (1997) [Pe] = Pearson et al. (1995) [Pl] = Ploeg et al. (2003) (a) = No RCTs, only audit reports, surveys and medical records review. (b) = Not Transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed

GRADE profile 2: Use of clinical triggers

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration Conversion rate 1 study S NA S S Very low (a) (b) (c) Outcome 2004 2005 p value 1 x observational Conversion 50% 80% 0.025 study- [B] rate

A study showed that the conversion rate statistically significantly increased when clinical triggers were used to screen all ICU patients. Number of organ donors 1 study S NA S S A study showed that the number of organ donors in Collaborative hospitals increased 14.1% in the first year, a 70% Very low (a) (b) (c) greater increase than the 8.3% increase experienced by non-Collaborative hospitals. Moreover, the increased 1 x observational organ recovery continued into the post-Collaborative periods. study- [S] Number of potential and effective donors 2 studies S NA S S The number of potential donors increased between 4% to 27.46% Very low

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration (a) (b) (c) The number of effective donors increased by 22% to 30.86%. 2 x observational studies- [Sh] and [V] Total number of referrals 1 study S NA S S Total referrals increased 26% in the project IHC LITCs vs. 14% in the comparison hospitals with no IHC LITCs Very low (a) (b) (c) 1 x observational study- [Sh] [B] = Bair et al. (2006) [S] = Shafer et al. (2008) [Sh] = Shafer et al. (2004) [V] = Van gelder et al. (2006) IHC-in-house cordinators LITC- Level I trauma centers (a) = No RCTs, only audit reports, surveys and medical records review. (b) = Not Transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed

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GRADE profile 3: Use of required referral

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration Referral rate and number of potential donors 1 study S NA No S Low (a) serious (c) 2006-7 2007-8 1 x observational study- [M] Number Non- Heart Non-heart Heart heart beating beating beating beating donors donors donors donors Referred 2 1 7 31 Accepted 1 1 6 7

There was an increase in referral rate. There was an increase in the number of potential donors referred to the OPO representative. Referral rate and number of potential donors 5 studies S NA S S There was an increase in referral rate of between 56% to 450% Very low (a) (b) (c) 4 x observational studies- [H], [Hi], There was an increase in the number of potential donors referred to the OPO representative of [R], and [S] between 3% and 80%

1 x retrospective study- [B] Number of donors 6 studies S NA S S Studies showed that there was an increase in the number of donors of between 24% and Very low (a) (b) (c) 275% from potential donors. 3 x observational studies- [S], [R], and [Sh]

3 x retrospective studies- [B], [D], and [G]

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration Number of organs retrieved per donor 1 study S NA S S A study showed that there was an increase of 312% for the number of organs retrieved per Very low (a) (b) (c) donor. 1 x observational study- [S] Number of organs retrieved per donor 1 study S NA S S But one study showed that the overall number of organs per donor was essentially unchanged Very low (a) (b) (c) from the baseline year. 1 x retrospective study-[G] [M] = Murphy et al. (2009) [H] = Higashiwaga et al. (2001) [Hi] = Higashiwaga et al. (2002) [R] = Robertson et al. (1998) [S] = Shafer et al. (1998) [B] = Burris et al. (1996) [Sh] = Shafer et al. (2008) [D] = Dickerson et al. (2002) [G] = Graham et al. (2009) (a) = No RCTs, only audit reports, surveys and medical records review. (b) = Not transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed

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Review question 2: What structures and processes are appropriate and effective for obtaining consent from families, relatives and legal guardians of potential DBD and DCD donors? Where possible, imprecision was assessed. Where imprecision was not assessed this was because the type of evidence included often did not allow any assessment of the preciseness of any summary estimate or because the evidence was qualitative.

GRADE profile 4: Effect of ‘collaborative requesting’ on consent rate for organ donation Summary of findings Quality assessment No of patients Effect No of Other Results Quality Design Limitations Inconsistency Indirectness Imprecision Collaborative Routine studies considerations (95% CI) Consent to organ donation (ITT) 1 RCT S NS NS S none 57/100 62/101 [Y] (a) (b) OR- 0.83 (95% CI-0.47 to 1.46) Low (57.0%) (61.4%) Consent to organ donation (Adjusted for ethnicity, gender, and age) 1 RCT S NS NS S none 57/100 62/101 OR- 0.80 (95% CI- 0.43 to 1.53, p = 0.49) Low [Y] (a) (b) (57%) (61.4%) Any solid organ retrieved from all patients (ITT) 1 RCT S NS NS S none 45/100 57/101 [Y] (a) (b) OR- 0.63 (95% CI- 0.36 to 1.10) Low (45.0%) (56.4%) Any solid organ retrieved from patients who consented (ITT) 1 RCT S NS NS S none 45/79 57/92 OR- 0.81 (95% CI- 0.44 to 1.50) Low [Y] (a) (b) (57.0%) (62.0%)

[Y] = Young et al. (2009) Collaborative request (Relatives approached by clinical team and a donor transplant coordinator) vs. routine request (Relatives approached by the clinical team alone) (a) = Blinding not performed. (b) = Total no. of events < 300.

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GRADE profile 5: Views of families of potential adult donors

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration

Influence of staff involved in organ donation 1 study S NA S S A study showed that family members felt that presence of and interaction with nursing staff were strongly Very low (a) (b) (c) valued by both donor and non-donor family members; satisfaction with nurses’ behaviors and care was 1 x Qualitative expressed by all, and nurses were seen as a source of emotional support. Study- [J] 1 study S NA S S A study showed that family members felt that treating physicians are not readily available to families, don’t Very low (a) (b) (c) provide continuity of care and information, don’t use simple language, do not verify whether the families 1 x Qualitative have understood everything being explained to them by the physicians. Study - [J] 1 study S NA S S A study showed that donor families found it easier to talk to donor coordinators because they did not wear Very low (a) (b) (c) any uniform. 1 x Qualitative retrospective study- [H] 1 study S S S S A study showed that there were variations in the family experiences while being approached for consent Very low (a) (d) (b) (c) on organ donation. 1 x Qualitative Study - [J] Continuity of care 1 study S NA S S A study showed that families preferred continuity of care for their loved ones which was sometimes Very low (a) (b) (c) considered inadequate to increase consent for organ donation. 1 x Qualitative Study - [J] 1 study S NA S S A study showed that families of potential donors preferred to interact with a single physician. Very low (a) (b) (c) 1 x Qualitative Study - [J] Quality of approach 2 studies S NA S S Studies showed that both families of donors and non-donors wanted compassionate care of their loved Very low (a) (b) (c) one (potential donor) and their being treated with dignity and respect.

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 x Qualitative retrospective study- [H] 1 x Qualitative Study - [J] 1 study S NA S S A study showed that families wanted to be listened to by the staff and the staff to be there for them when Very low (a) (b) (c) needed. 1 x Qualitative Study - [J] Provision of information 2 studies S NA S S Studies showed that both families of donors and non-donors wanted understandable, prompt, accurate, in- Very low (a) (b) (c) depth and consistent information. 2 x Qualitative Studies - [J] and [S] 2 studies S NA S S Studies showed that the different kinds of information required by families included the meaning of brain- Very low (a) (b) (c) stem death, the confirmation of death, the reasons for brain-stem testing, other medical information related 1 x Qualitative retrospective to the condition of the potential donor, and the whole process of organ donation. Also, it should be made study- [H] sure that families have understood clearly what they were told and what they asked for. 1 x Qualitative Study - [J] 1 study S NA S S A study showed that both families of donors and non-donors considered the tone and pace of information Very low (a) (b) (c) giving to be critical. Families considered that they were rushed and pressured, and information was 1 x Qualitative conveyed insensitively. They wanted the information to be conveyed with empathy, concern, and Study - [J] consideration. 1 study S NA S S A study showed that both families of donors and non-donors considered privacy for the discussion to gain Very low (a) (b) (c) consent for organ donation as being critically important. 1 x Qualitative Study - [J] Sources of support 1 study S NA S S A study showed that families viewed nurses as a source of support during the discussion to gain consent Very low (a) (b) (c) for organ donation.

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 x Qualitative Study - [J] 1 study S NA S S A study showed that families of donors believed that that faith and spiritual support was important to them Very low (a) (b) (c) during the discussion to gain consent for organ donation but non-donor families believed this support to be 1 x Qualitative of less importance. Study - [J] 1 study S S S S A study showed that some donor families found follow-up care to be useful which helps them to ask further Very low (a) (d) (b) (c) questions and to make the donation feel more personal and sincere following discussion to gain consent 1 x Qualitative retrospective for organ donation. But, not all donor families thought this to be useful. study- [H] Views of physicians involved in organ donation 1 study S NA S S A study showed that physicians involved in the organ donation process considered important the need to Very low (a) (b) (c) be certain of decisions and of the process and also found the entire process very stressful. 1 x Qualitative Study - [S] Factors associated with decision stability or satisfaction 1 study S NA S S A study showed that one factor associated with consent in potential adult donors was an understanding of Very low (a) (b) (c) the term brain death. 1 x Retrospective study- [B] Factors associated with decision instability or dissatisfaction 1 study S NA S S A study showed that the factors associated with denial of consent in potential adult donors were: Very low (a) (b) (c) 1 x Retrospective study- [R] a lack of discussion of donation with the deceased poor timing of donation discussion not being told of the death before the first mention of donation not being given enough time to discuss the donation decision with others Factors associated with the decision to grant consent 12 studies S NA S S Studies showed that the following factors were associated with families of potential donors granting Very low (a) (b) (c) consent to organ donation:

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 7 x Retrospective studies- [B], [Br], [M], [F], [D], [N], [Si understanding that transplantation was a proven procedure had a high success rate, and & L] knowledge of the benefits or organ donation 1 x Retrospective study an understanding of the term brain death (chart review and acceptance of death, and confidence in the ‘diagnosis of death’ interviews)- [Si-b] consideration and knowledge of the deceased’s wishes (through carrying a donor card or 2 x Retrospective studies discussion) (survey)- [Si], [P] earlier timing of request 1 x Cross sectional survey- involving more family members with the decision [C] the level of comfort with which the healthcare professional requested consent 1 x Retrospective cross good relationships between the family and the healthcare professionals sectional qualitative study- satisfaction with treatment (either of the family or the deceased) [Sq] congruence between the views of healthcare professionals and the families at initial approach request for donation being initiated by a healthcare professional (not a physician) with further discussion with an organ donation professional request by different healthcare professionals more time spent with an organ donation professional knowledge of the impact of donation on other processes, such as funeral arrangements knowledge of the costs of donation choice of organs for donation families being able to discuss both specific and wider issues and getting answers to questions Factors associated with the decision to refuse consent 18 studies S NA S S Studies showed that the following factors were associated with families of potential donors refusing Very low (a) (b) (c) consent to organ donation: 11 x Retrospective studies- [B], [Br], [M], [D], [Si & L], [La feelings of pressure to consent S], [No], [So], [Do], [Sh] and feeling emotionally overwhelmed [Ch] feeling of surprise on being asked about consent 1 x Cross sectional survey- fear of causing more ‘suffering’ or disfigurement, and not wanting the deceased to have more [C] medical intervention

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 x Retrospective cross concern that donation may cause more distress to family members sectional qualitative study- uncertainty about the deceased’s wishes [Sq] reluctance to accept the death 1 x Retrospective study social resentment (chart review and lack of understanding and confidence in the concept of brain-stem death interviews)- [Si-b] lack of family consensus and the family being ‘upset’ 2 x Retrospective studies family reticence (survey)- [Si], [P] making the decision before information was provided by a healthcare or organ donation 1 x Prospective study- [Si-a] professional an absence of key decision makers the length of the process not liking the hospital or healthcare professionals feeling that the medical care was not optimal initial approach by a healthcare professional perception that the healthcare professional did not care or was not concerned, or the healthcare professional showing a lack of respect healthcare professionals stating that the request was required lack of knowledge of the impact of donation on other processes, such as funeral arrangements lack of detailed information on the process of organ donation, including the timing of retrieval and information on recipients initial perception of healthcare professionals that the family were likely to refuse. Other factors influencing consent for organ donation 12 studies S S S S Studies showed that other factors that influenced the families of potential donors in obtaining consent Very low (a) (d) (b) (c) were: 7 x Retrospective studies- [B], [Br], [M], [Si & L], [La S], donor ethnicity [F] and [No] donor age 1 x Retrospective study donor sex (chart review and type of death (trauma or not) interviews)- [Si-b] familial (or consentor)

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 2 x Retrospective studies level of education (survey)- [Si], [P] socioeconomic status 1 x Prospective study marital status, previous examples of belief in or support for organ donation (such as carrying a (survey)- [Yo] donor card or donating to relevant charities) 1 x Retrospective study religious, cultural or spiritual beliefs (audit)- [Pi] personal experience or knowledge of transplantation setting of donation or death However, some associations were not consistent across studies. [J] = Jacoby et al. (2005) [H] = Haddow (2004) [S] = Sanner et al. (2007) [B] = Burroughs et al. (1998) [R] = Rodrigue et al. (2008) [Si-b] = Siminoff et al. (2001b) [Br] = Brown et al. (2010) [Si] = Siminoff et al. (2002) [P] = Pearson et al. (1995) [M] = Martinez et al. (2001) [F] = Frutos et al. (2002) [D] = Douglas (1994) [C] = Cleiren and Van Zoelen (2002) [Sq] = Sque et al. (2007) [N] = Niles et al. (1996) [Si & L] = Siminoff and Lawrence (2002) [La S] = La Spina et al. (1993) [No] = Noury et al. (1996) [So] = Sotillo et al. (2009) [Ch] = Chapman et al. (1995) [Yo] = Yong et al. (2000) [Pi] = Pike et al. (1990) [Do] = Douglass et al. (1995)

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[Si-a] = Siminoff et al. (2001a) [Sh] = Shaheen et al. (1996) (a) = No RCTs, only audit reports, surveys and medical records review. (b) = Not Transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed (d) = inconsistent themes and results from study

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GRADE profile 6: Views of families of potential paediatric donors

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration Influence of staff involved in organ donation 1 study S NA S S A study showed that parents of potential paediatric donors were more likely to give consent if they had a good Very low (a) (b) (c) relationship with the ICU personnel and then were more likely accept the irreversibility of their child’s death. 1 x qualitative study- Conversely, where this relationship was poor or when staff did not allow parents to be at the child’s bedside, [B], [Be-a], [Be-b] parents of potential paediatric donors were less likely to give consent. Influence of family members 1 study S NA S S A study showed that parents of potential paediatric donors tended to make the final decision about consent with Very low (a) (b) (c) their spouse but extended family members played a significant role in the decision making process to gain 1 x qualitative study- consent. In cases where parents of potential paediatric donors lacked spousal or mate support, consent for [Be-a], [Be-b] donation was less likely. Factors related to consent 1 study S NA S S A study showed that parents of potential paediatric donors gave consent when they were able to accept their Very low (a) (b) (c) child’s death, attribute meaning to the donation (for example, the benefits to the recipient) and when also believed 1 x qualitative study- that consent was consistent with their child’s wishes. [B], [Be-a], [Be-b] 1 study S NA S S A study showed that parents of potential paediatric donors were more likely to decline consent when they had no Very low (a) (b) (c) prior knowledge about organ donation, wanted to know the recipient, considered that their child had been 1 x qualitative study- inappropriately cared for, or were unaware of their church’s position on organ donation. [B], [Be-a], [Be-b] 1 study S NA S S A study showed that other factors related to obtaining consent from parents of potential paediatric donors Very low (a) (b) (c) included; 1 x qualitative study- [B], [Be-a], [Be-b] fear of mutilation or disfigurement subjecting the child to further ‘ordeal’ a reluctance to assume responsibility for another’s organs 1 study S NA S S A study showed that parents of potential paediatric donors who gave consent reported feeling that their grief was Very low (a) (b) (c) eased, through helping others to live or feeling that their child was living on through others. 1 x qualitative study-

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration [Be-a], [Be-b] Method of approach 1 study S NA S S A study showed that parents of potential paediatric donors were more likely to give consent when family members Very low (a) (b) (c) or friends were approached by health care professionals, and they then approached the parents (indirect 1 x qualitative study- approach). [B] Quality of approach 1 study S NA S S A study showed that parents of potential paediatric donors were more likely to decline consent when they the Very low (a) (b) (c) parents were informed in an inappropriate manner and pressured to make a decision. 1 x qualitative study- [B], [Be-a], [Be-b] Provision of information 1 study S NA S S A study showed that parents of potential paediatric donors requested the following information before giving Very low (a) (b) (c) consent for organ donation; 1 x qualitative study- [Be-a], [Be-b] the process of organ retrieval the outcomes of transplantation the identity of the recipient the possibility of making contact with him or her 1 study S NA S S A study showed that parents of potential paediatric donors experienced more distress and were less likely to give Very low (a) (b) (c) consent if they were not given information on; 1 x qualitative study- [Be-a], [Be-b] the child’s condition the chance of survival of the child the concept of brain death 1 study S NA S S A study showed that parents of potential paediatric donors who had given consent for organ donation wanted Very low (a) (b) (c) more information on what happened next, including the process of burial. 1 x qualitative study- Some parents of potential paediatric donors expressed resentment and anger at healthcare professionals who [Be-a], [Be-b] never expressed concern about their well-being during the period following the child's death. They also felt that their act was not socially recognised, that they were quickly forgotten, and few even believed

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration that they had been exploited. Factors associated with the decision to grant consent 2 studies S NA S S Studies showed that the following factors were associated with families of potential paediatric donors granting Very low (a) (b) (c) consent to organ donation: 1 x Retrospective study- [V] belief in the process of donation, and feeling that it was ‘the right thing to do’ 1 x Retrospective perception that the child would go on living in others study (survey)- [W] good interaction with healthcare professionals involved in organ donation type of healthcare professional who asked for consent.

Factors associated with the decision to refuse consent 2 studies S NA S S Studies showed that the following factors were associated with families of potential paediatric donors refusing Very low (a) (b) (c) consent to organ donation: 2 x Retrospective studies (survey)- [W] a perception that the doctors who determined death were not part of the organ donation process and [F] lack of information fear or lack of belief in organ donation perception that timing of approach was not optimal feeling that the child had been through enough and fear of further trauma concern that donation would impact on survival consideration of donation was too upsetting poor interaction with healthcare professionals involved in organ donation, including a perception of insensitivity. Other factors influencing consent for organ donation 2 studies S NA S S Studies showed that other factors that influenced the families of potential paediatric donors in obtaining consent Very low (a) (b) (c) were: 1 x Retrospective study (survey)- [F] donor ethnicity

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 x Retrospective familial (or consentor) ethnicity study- [P] religious beliefs previous examples of belief in or knowledge of transplantation. [B] = Bellali et al. (2006) [Be-a] = Bellali et al. (2007-a) [Be-b] = Bellali et al. (2007-b) [V] = Vane et al. (2001) [W] = Weiss et al. (1997) [F] = Frauman et al. (1987) [P] = Pietz et al. (2004) (a) = No RCTs, only audit reports, surveys and medical records review. (b) = Not transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed (d) = inconsistent themes and results from study

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Review question 3: When is the optimal time for approaching the families, relatives and legal guardians of potential DBD and DCD donors for consent? GRADE profile 7: The optimal time for approaching the families, relatives and legal guardians of potential DBD and DCD donors to gain consent.

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration Approach before death 2 studies S NA S S Studies showed that when families of potential donors were asked about donation before death of their loved one, Very low (a) (b) (c) they tended to have a higher chance of giving consent than those asked at the time of death or after death. 2 x retrospective studies- [N] and [S] Approach after death 1 study S NA S S A study also showed that when families of potential donors were asked about donation following notification of Very low (a) (b) (c) death of their loved one, as opposed to before or simultaneously with notification of death, they tended to have a 1 x retrospective higher chance of giving consent. study- [C] Time difference between approaches 1 study S NA S S A study showed that when time from admission to initiation of brain death protocol was examined, success was Very low (a) (b) (c) obtained when a mean delay of 15.5 hours was respected vs. a mean delay of 7.0 hours when donation was requested but denied. 1 x retrospective study- [V] Factors associated with optimal time to approach families of adult potential donors 1 study S NA S S A study showed that families who had denied consent had not been given enough time to prepare them for organ Very low (a) (b) (c) donation and had not been clearly informed that their loved one (potential donor) was brain dead. 1 x qualitative Study - [J]

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 3 studies S NA S S Studies showed that families of potential adult donors thought that time was needed to allow families to recover Very low (a) (b) (c) from shock, to consider the benefits of donation, allow them sufficient time to discuss the decision with other family 2 x qualitative members, and to understand the concept of brain-stem death. studies -[J] and [S] 1 x qualitative retrospective study- [H] 1 study S NA S S A study showed that families of potential adult donors who gave consent thought that the timing of the approach Very low (a) (b) (c) was ‘as good as could have been’ and had time to spend with the family member and to say goodbye. 1 x qualitative Study- [J] Factors associated with optimal time to approach families of paediatric potential donors 1 study S NA S S A study showed that parents of potential paediatric donors felt that the indirect approach for consent gave them Very low (a) (b) (c) time to consider the request for donation before the discussion with the physician. 1 x qualitative study- [B] 1 study S NA S S A study showed that parents of potential paediatric donors felt distressed and tended to refuse consent if they were Very low (a) (b) (c) not given the chance to see their child and say their goodbye. 1 x qualitative study- [Be-a], [Be-b] [N] = Niles et al. (1996) [S] = Siminoff et al. (2002) [C] = Cutler et al. (1993) [V] = Vane et al. (2001) [J] = Jacoby et al. (2005) [H] = Haddow (2004) [S] = Sanner et al. (2007) [B] = Bellali et al. (2006) [Be-a] = Bellali et al. (2007-a) [Be-b] = Bellali et al. (2007-b) (a) = No RCTs, only audit reports, surveys and medical records review.

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(b) = Not transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed

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Review question 4: How the care pathway of deceased organ donation should be coordinated to improve potential donors giving consent? GRADE profile 8: Coordination of the pathway for organ donation and consent from families

Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration Donor referrals 2 studies S NA S S Studies showed that there was an increase in the donor referrals of between 46% to 450% when hospitals had Very low (a) (b) (c) in-house coordinators coordinating the process in hospitals 1 x observational study- [S] 1 x retrospective study- [R] Consent rates 1 study S NA S S A study showed that despite demographic differences, the 8 centers with in-house coordinators had higher Very low (a) (b) (c) consent rates (60% vs. 53%) than hospitals without in-house coordinators 1 x observational study- [Sh] Conversion rates and number of donors 4 studies S NA S S Studies showed that there was an increase in the conversion rates of potential donors of between 32% and 67% Very low (a) (b) (c) when hospitals had in-house coordinators coordinating the process in hospitals compared to hospitals without in- 2 x observational house coordinators. studies- [S] and [Sh] Also there was an increase of 275% in the number of donors when hospitals had in-house coordinators 2 x retrospective coordinating the process in hospitals compared to hospitals without in-house coordinators. studies- [R] and [A] Number of organs recovered 1 study S NA S S Studies showed that there was an increase of between 70% to 312% in the number of organs recovered from Very low (a) (b) (c) donors when hospitals had in-house coordinators coordinating the process in hospitals compared to hospitals 1 x observational without in-house coordinators. study- [S]

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Study characteristics Summary of findings

Analysis Quality

No. of studiesNo.of Limitation Inconsistency Indirectness Other consideration 1 x retrospective study- [R] [S] = Shafer et al. (1998) [R] = Roth et al. (2003) [Sh] = Shafer et al. (2004) [A] = Al-Sebayel et al. (2004) (a) = No RCTs, only audit reports, surveys and medical records review. (b) = Not transferable to other population addressed because studies carried out when specialist nurses for organ donation were not in place and certain interventions were not in place, and some studies not carried out in UK and legislative rules vary in different countries (c) = Limited analyses performed.

Review question 5:

What key skills and competencies are important for healthcare professionals to improve the structures and processes for identifying potential DBD and DCD; to improve structures and processes for obtaining consent; and to effectively coordinate the care pathway from identification to obtaining consent?

As noted above, evidence from other questions was used to inform recommendations on skills and competencies needed. There are therefore no GRADE profiles for this question.

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Appendix D Evidence tables Review Question 1: What structures and processes including timing for referral and criteria for consideration are appropriate and effective for identifying potential DBD and DCD donors? Title: The organ donation crisis: The missed organ donation potential from the accident and emergency departments. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The criteria used to identify potential N/A Main barriers cited by health care 154 770 deaths audited out /Exclusion (study donors were based on UK transplant staff as to WHY patients may not be of 1204 deaths group): criteria for potential heart-beating or recognized as potential donors in Author: controlled non-heart beating organ the A&E department: Aubrey et al. Control group: Not mentioned donors. (2008) N/A Non recognition of potential Characteristics of donors Study type: Study period: cases: Lack of confidence and Retrospective Oct. 2004 to Dec. 2005 Not mentioned experience of A&E staff in offering study (audit) the option of donation to acutely Setting: Baseline bereaved families 10 accident and Measurements: No contact details for donor emergency (A&E) Not applicable transplant coordinator (DTC) departments in the North Shortage of intensive care beds Thames region HM coroner involvement seen as too complex Limited resources – physical space and manpower.

The main causative factor for non- donation from within A&E departments in the UK is due to an inadequate organ donor program.

It is imperative that key health care professionals and the bereaved relatives are identified.

The key professionals are based hospital wide and not just in the A&E

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department.

Identified key personnel are:

Hospital consultants – A&E, anesthetists and neuro-surgeons Emergency trauma team A&E nursing and medical staff HM coroners and HM coroners officers Additional comments:

Reference: Aubrey, P, Arber, S, Tyler, M The organ donor crisis: the missed organ donor potential from the accident and emergency departments. Transplantation Proceedings 2008; 40: 1008-11.

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Title: Number of potential cadaveric donors: reasons for nonprocurement and suggestions for improvement. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion Performed continuous registration of potential N/A A diagnosis of total cerebral infarction was 865 group: /Exclusion (study cadaveric donors to assess donor availability and made prior to cardiac arrest in 18% of Not group): reasons for non-procurement. patients who died while on ventilator Author: reported support Gabel and Not mentioned Cases in which a diagnosis of total cerebral Edstrom Control infarction was made were reported together with Of these, treatment was discontinued in (1993) group: Characteristics of details of whether treatment was discontinued 80% and only 47% became donors N/A cases: with adequate peripheral circulation. Study type: Not mentioned 17% had valid medical or age-related Audit report Study Information regarding suitability of the patient for contraindication to organ donation and in period: Baseline organ donation and circumstances when suitable others consent was not given. May 1989 measurements: organs were not procured were also reported. to Dec. Not applicable. Organ donation was not discussed with 1991 relatives in 7% No relative could be located in 2% Setting: Sweden The survey estimates there were at most 30 donors per million with no medical or age-related contraindication to organ donation were missed. Additional comments:

Reference: Gabel, H, Edstrom, B. Number of potential cadaveric donors: reasons for nonprocurement and suggestions for improvement. Transplantation Proceedings 1993; 25: 3136.

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Title: Detection of potential organ donors: a 2-year analysis of deaths at a German university hospital. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion /exclusion Analysed the factors that might lead to under N/A Among 1312 deaths, organ donation 56 group: (study group): detection or loss of potential organ donors at the should have been considered in 114 1312 hospital. cases, but was actually considered in 76. Author: deaths Not mentioned Petersen et al. The hospital’s electronic database for deaths In 38/114 cases, organ donation was (2009) Control Characteristics of related to cerebral complication was examined, as missed of which 19 were admitted to ICU group: cases: well as additional diseases, neurological findings, and 17 admitted to peripheral wards. Study type: N/A Not mentioned donation requests, and donations realised. retrospective Death due to cerebral complications study Study Baseline occurred within 48 hours but medical period: measurements: records were not plausible in terms of 2006- Not applicable exclusion criteria for organ donation. 2007

Setting: Sweden Additional comments:

Reference: Petersen, P, Fischer-Frohlich, CL, Konigsrainer, A, Lauchart, W. Detection of potential organ donors: 2-year analysis of deaths at a German university hospital. Transplantation Proceedings 2009; 41: 2053-54.

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Title: Knowledge and attitudes of physicians regarding organ donation. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion To describe Canadian physicians’ N/A The greatest barrier to organ donation was 746 2,400 /Exclusion (study knowledge, commitment, and professional lack of knowledge about referral processes; questionnaires group): involvement relating to organ donation, and 44.6% of physicians reported they did not Author: sent to identify factors related to personal know how to refer a potential organ donor Molzahn 831 physicians Not mentioned commitment and professional involvement. to the organ-procurement agency. (1997) responded Characteristics of The questionnaire included sections on 95.4% of physicians strongly approved of Study type: Control group: cases: demographic characteristics, knowledge of organ donation Retrospective N/A Not mentioned and attitudes toward organ donation, 68.3% felt comfortable identifying organ study willingness to facilitate the donation process, donors Study period: Baseline and experience with organ donation. 47.2% believed that brain death is difficult Not mentioned measurements: to explain to families. Not applicable. 57% agreed that they do not like to become Setting: involved in organ donation Canada 16% were concerned about potential liability 74.6% reported that organ donation was emotionally demanding 75% reported other health professionals were reluctant to approach families about organ donation.

Strategies to improve organ donation

65.8% supported the idea that hospitals should be required to participate in organ donation 85.3% agreed that hospital protocols should be developed for assessing ventilated patients as potential organ donors. Additional comments:

Reference: Molzahn, AE Knowledge and attitudes of physicians regarding organ donation. Annals of the Royal College of Physicians & Surgeons of Canada 1997; 30: 29-32.

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Title: Shortage of donation despite an adequate number of donors: A professional attitude? Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion To chart the donor potential for organs in The N/A Maximum potential- 922 out of 4877 486 5000 deceased /Exclusion (study Netherlands and identify factors influencing whether deceased patients patients group): donation is discussed with the relatives and whether Optimistic potential- 205 Author: 4877 filled D- donation request is granted or refused. Realistic potential- 61 out of 205 Ploeg et al. forms Not mentioned (2003) 717 physicians The donation form (D-form) was constructed to Out of 61, only in 42 (69%) was the Characteristics of obtain information at the time of death of patients. topic of donation raised. Study type: Control group: cases: Prospective N/A Not mentioned In calculating the organ-donor potential in the Of 717 physicians in the study, 301 study hospitals included in the study, 3 possible scenarios (42%) asked the organ donation Study period: Baseline were used: question one or more times. Not mentioned Measurements: The reasons given for not discussing Not applicable. 1. Maximum potential: which donation were: Setting: included all deceased patients that had no specific 11 hospitals in contraindications and were below the proper age Medical contraindication-50% The thresholds. No time – 10% Netherlands Did not think of it – 5% 2. Optimistic potential: which Difficult situation – 4% included all deceased patients who had a diagnosis Other reasons –18% that could lead to brain death. In the multilevel analysis, the chance 3. Realistic potential: the that a physician raises the donation numbers obtained in the optimistic potential were request varies between 2% and 77% used, with the addition of artificial respiration and brain death. Factors that had a strong and significant influence on whether or not the donation request was done were:

Number of potential organs in a particular donor (p = 0.000) Knowledge of contraindications by physician (p = 0.000) Cause of death (p = 0.026) with natural causes of death

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Sex of the physician (p = 0.035) female physicians are more likely to ask than male colleagues.

Factors that did not influence were:

Sex of the patient Time of death Presence of a codicil Age of the physician Position of the physician Frequency with which the physician confirmed death. Additional comments: Reference: Ploeg, RJ, Niesing, J, Sieber-Rasch, MH, Willems, L, Kranenburg, K, Geertsma, A Shortage of donation despite an adequate number of donors: a professional attitude? Transplantation 2003; 76: 948-55.

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Title: Organ donor potential and performance: size and nature of the organ donor shortfall. Study type No. of Prevalence/ Patient characteristics Methods Reference Results people incidence standard ID: Study N/A Inclusion /Exclusion (study To estimate the N/A Organ donation occurred among 299 of the 916 potential donors 789 group: group): potential for [33% (95% CI 30–36)] 69 solid organ Author: hospitals Patients were checked to donation and Rates of organ donation decreased substantially with the potential Gortmaker et in a non see if they met the criteria for identify donor’s age: al. (1996) random brain death. modifiable 41% among ages 0 to 18 years to 12% among ages 60-70 years (p= sample The study was limited to reasons for 0.0001) Study type: 956 potential donors who were non-donation. Retrospective medically ≤ 70 years of age at time of Donation was also lower among African American (22%) and study (medical suitable death. Patients were . Hispanic subjects (17%) compared with non-Hispanic white subjects records review) potential excluded if they had been (41%, p < 0.0001). donors diagnosed with one or more 40 records of 13 categories of ICD-9- Rates of donation were higher when the cause of death was a motor missing CM contraindications for vehicle accident (45%), a gunshot wound or stabbing (43%), or 916 organ donation. other head trauma (42%) compared with cerebrovascular (26%), complete asphyxiation (21%), or cardiovascular (3.2%) (p < 0.001). data Characteristics of cases: available Not mentioned No relationship between size of the 69 hospitals (number of beds) and the donation rate in that hospital which suggests there is no Control Baseline measurements: volume or experience effect. Also, whether or not the hospital was a group: Not applicable. transplant center did not affect the rate of donation. N/A Table 1 Predictors of organ donation Study period: Predictor Multivariate 95% CI p value Jan 1990 variables Odds to Dec. Age (years) 1990 0-18 5.75 2.75- 0.0001 12.04 Setting: 19-29 3.51 1.77-6.98 0.0003 USA 30-39 5.00 2.50- 0.0001 10.01 40-49 5.10 2.60- 0.0001 10.00 50-59 2.16 1.04-4.50 0.04

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≥60 1.00 race/ethnicity Africa 0.38 0.23 0.63 0.0001 American Hispanic 0.26 0.13-0.49 0.0001 White (non- 1.00 Hispanic) All other 0.25 0.11-0.57 0.0009 Cause of death Gunshot 2.70 1.58-4.62 0.0003 wound/stabbing Motor vehicle 2.22 1.40-3.51 0. 07 Other head 1.00 trauma Cerebrovascular 1.33 0.84-2.10 0.22 All other 1.23 0.66-2.30 0.52 Estimated OR from logistic regression predicting donation (vs. no donation) among potential donors controlling for variables shown, hospital unit, and number of beds.

The odds of donation for patients aged0 to 49 years were approximately 5 times the odds of potential donors aged ≥60 years.

By contrast, the odds of donation were substantially lower for African Americans (OR 0.38, 95%CI 0.23-0.63. p < 0.0001) compared with non-Hispanic whites.

Reasons for Non-donation

3 major reasons found were:

The main reason was denial of consent (36%) In addition (17%), brain death was evident but family members were not asked to make a decision about donation. 10% were not identified as brain dead in the records, despite clinical findings consistent with brain death.

Also, the rate of not asking was also independently associated with

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race/ethnicity. Compared with non-Hispanic white family members, family members of African American members were less likely to be asked to donate (OR 0.34, 95% CI 0.20–0.62, p = 0.0003). Additional comments: Reference: Gortmaker, SL, Beasley, CL, Brigham, LE, Franz, HG, Garrison, RN, Lucas, BA, Patterson, RH, Sobol, AM, Grenvik, NA, Evanisko, MJ Organ donor potential and performance: size and nature of the organ donor shortfall. Critical Care Medicine 1996; 24: 432-39.

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Title: A survey of personal and professional attitudes of intensivists to organ donation and transplantation. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion A questionnaire survey was carried N/A 80 out of 242 from 49 hospitals said they had a unit 819 293 /Exclusion (study out to examine the attitudes and policy according to which families should be intensivists group): practices of Australian and New approached for organ donation. Author: replied Zealand intensivists with regard to Pearson et al. Not mentioned brain death and organ donation. Unit policy was ‘all families without exception’ in 26, (1995) Control ‘all with agreed exceptions’ at 14 and ‘all with ad hoc group: Characteristics of Each questionnaire consisted of a exclusions’ in 40. If the latter was assumed to be Study type: N/A cases: personal details section, personal equivalent to no policy at al, that implied that only 40 retrospective Not mentioned attitudes, and unit/hospital practice had a policy in practice. study Study period: and policy. 1992 Baseline Table 1 The most common reasons for not asking Measurements: about organ donation Setting: Not applicable. Australia and Reasons for not asking Total New Zealand Cultural differences 106 Family too distressed 104 Language difficulties 49 Too tragic 48 Threats to staff 35 Other 22 Insufficient beds 12 Insufficient nurses 9 You are too stressed 9 Nurses too stressed 5

Additional comments:

Reference: Pearson, IY, Zurynski, Y A survey of personal and professional attitudes of intensivists to organ donation and transplantation. Anaesthesia & Intensive Care 1995; 23: 68-74.

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Title: Improving donor identification with the Donor Action Programme Study type No. of Prevalence/ Patient characteristics Methods Reference Results people incidence standard ID: Study N/A Inclusion /Exclusion To analyse the problem of identification of potential N/A The number of evaluated deaths 517 group: (study group): donors by means of a chart revision of patients who was 649, 654, 573, 593 and 587 in 14 ICUs died in 14 ICUs. each period. Author: Not mentioned Pugliese et al Control The Donor Action Programme (DA) provides tools The number of brain dead diagnosis (2003) group: Characteristics of cases: and guidelines to assist hospitals and critical care was performed in 87 in 1st semester, N/A Not mentioned units in assessing and improving their donation 91-2nd, 88-3rd, 118-4th, and 125-5th. Study type: potential. Retrospective Study Baseline Measurements: This is a significant increase in brain study period: The demographic The study period was subdivided into 5 semesters, death diagnosis from the beginning July 1998 characteristics of the and every 6 months the following parameters were to the end of the study from 31% to to Dec. study population, age evaluated: 53% (p = 0.003, χ2- 16.072). 2000 and gender, remained stable in the analysed 1. The number of patients with severe brain A consensual enhancement of Setting: periods. damage/total number of deaths in ICU potential donor referrals was also Emilia 2. The number of brain death diagnosis/patients observed. Organ donor referrals to Romagna with GCS=3. the transplant reference centre has region All patients with severe brain insult as defined by a increases from 84 to 112 (p = 0.008, GCS value of 3/15, who were admitted to, and died χ2- 13.779) since the implementation in, ICUs, were assessed by the local transplant co- of the DA project. coordinators. The co-coordinators entered the medical chart data into a local network that connected all ICUs to the transplant reference centre in real time. The accuracy of the data and the maintenance of homogenous criteria among all the hospitals taking part in the study were guaranteed by continuous controls through the professionals at the transplant reference centre, who verified the compilation of the schedules from each ICU through weekly contacts with the transplant coordinators and the ICU staff. Additional comments: Reference: Pugliese, MR, Degli, ED, Dormi, A, Venturoli, N, Mazzetti, GP, Buscaroli, A, Petropulacos, K, Nanni, CA, Ridolfi, L Improving donor identification with the Donor Action programme. Transplant International 2003; 16: 21-25.

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Title: Identifying the potential organ donor; an audit of hospital deaths. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion /Exclusion(study group): To identify all potential donors (not N/A Panel identified 90 1244 12 Victorian just those in ICUs). patients as possible hospitals Excluded those patients <1 year or >75 years of age potential donors Author: 5551 deaths or with an admission diagnosis of cancer. Also The panel members discussed 46-category 1-3 Opdam et al. excluded were patients medically not suitable for each case and classified which were (2004) Control donation (e.g. multi-organ dysfunction) or those who according to the following unrealised group: did not or could not progress to brain death. categories: 42-category 4 Study type: N/A 2 medically Prospective Characteristics of cases: 1. Confirmed brain death unsuitable. study (medical Study period: Not mentioned 2. Likely to progress to brain record audit) Not death with 24h Families not mentioned Baseline Measurements: 3. Likely to progress to brain approached for Not mentioned death with > 24h but < 72h donation Setting: 4. Not likely to progress to brain Physiological Victorian death within 72h or medically support not Hospitals, unsuitable for donation. provided Australia. Diagnosis of brain Categories 1-3 were considered to death missed be unrealised potential organ donors and category 4 was considered not to be potential organ donors.

Additional comments: Reference: Opdam, HI, Silvester, W Identifying the potential organ donor: an audit of hospital deaths. Intensive Care Medicine 2004; 30: 1390-1397.

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Title: Estimating the organ donor potential in Denmark: A prospective analysis of deaths in intensive care units in Northern Denmark. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion /Exclusion To estimate the organ donor potential in Denmark, N/A Medically suitable organ donors- 355 15 ICUs (study group): review causes of death in potential organ donors, 169 (10.2% of all deaths) 1655 deaths estimate the donation refusal rate and ascertain Cause of death was cerebral Author: Not mentioned reasons for non-donation. lesion in 96% of cases Madsen et al. Control Organ donation realised in 43 (2006) group: Characteristics of cases N/A cases: Study type: Not mentioned The rate of non detection by the Prospective Study period: hospital staff of medical suitable study Sept. 2000 to Baseline donors was estimated to be 2% August 2002 measurements: Not mentioned Setting: Denmark

Additional comments: Reference: Madsen, M, Bogh, L Estimating the organ donor potential in Denmark: a prospective analysis of deaths in intensive care units in northern Denmark. Transplantation Proceedings 2005; 37: 3258-59.

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Title: The identification of potential cadaveric organ donors. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion To identify why organ donation did not occur. N/A Phase 1: Metropolitan 818 Phase 1: 6080 /Exclusion(study hospitals deaths group): The study was undertaken in 2 phases: Author: Phase 2: 1326 863 patients in coma Thompson deaths Not mentioned Phase 1 515 acute irreversible brain et al. (1995) damage Control group: Characteristics of Prospective audit was undertaken of all patients Out of 515, 97 classified as Study type: N/A cases: who died in 9 metropolitan hospitals in NSW unrealistic potential donors Prospective Not mentioned over 12 months. Another 87 became study (audit) Study period: unrealistic Phase 1: April Baseline Phase 2 106 deemed medically 1991 to March Measurements: unsuitable 1992 Not mentioned A prospective 12 month audit undertaken of all 225 realistic medically Phase 2: Aug. patients who died in in 4 hospitals in country suitable potential donors 1992 to Jul. 1993 NSW. 48 resuscitation attempted Setting: but unsuccessful NSW, Australia 63 refused permission for donation 49 became actual donors BUT 65 classified as ‘missed’ potential donors

Phase 2:

1326 patients 103 potential donors 24 classified as unrealistic potential donors Another 14 became unrealistic 19 deemed medically unsuitable 46 realistic medically suitable potential donors

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15 resuscitation attempted but unsuccessful 9 refused permission for donation 11 became actual donors BUT 11 classified as ‘missed’ potential donors

Additional comments: Reference:Thompson, JF, McCosker, CJ, Hibberd, AD, Chapman, JR, Compton, JS, Mahony, JF, Mohacsi, PJ, Macdonald, GJ, Spratt, PM. The identification of potential cadaveric organ donors. Anaesthesia & Intensive Care 1995; 23: 75-80.

Title: Poisoned patients as potential organ donors; postal survey of transplant centres and intensive care units. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard

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ID: Study N/A Inclusion Postal questionnaires were sent to N/A Most directors would offer poisoned patients as 1387 group: /Exclusion (study transplant surgeons and/or physicians at all potential donors and leave the decision 67 doctors group): UK centres currently undertaking heart, lung, concerning organ harvesting to local Author: total kidney, liver or pancreas transplantation. transplantation team(s). Wood et al. 35 Not mentioned They were also sent to an equal number of (2003) surgeons directors of intensive care units at hospitals For the doctors, more than 70% of those 32 Characteristics of not undertaking transplantations. involved in transplantation would consider to Study type: physicians cases: accept patients who had been poisoned with Retrospective 30 Not mentioned methanol, cyanide or carbon monoxide as study directors organ donors. Baseline Control Measurements: group: Not mentioned N/A

Study period: Not mentioned

Setting: United Kingdom Additional comments: Reference: Wood, DM, Dargan, PI, Jones, AL. Poisoned patients as potential organ donors: Postal survey of transplant centres and intensive care units. Critical Care 2003; 7: 147-54.

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Title: National survey of potential heart beating solid organ donors in Sweden. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion /Exclusion The questionnaire consisted of 10 major questions N/A 217 were on mechanical ventilation 95 group: (study group): concerning brain injury, mechanical ventilation, death for at least 24 hours before death 875 diagnosis, and why donation did not take place 65 declared brain dead Author: deaths Not mentioned among potential donors. 56 considered medically suitable Moller et al. Transplant coordinator contacted in (2009) Control Characteristics of 52 cases group: cases: Study type: N/A Not mentioned 29 patients had expressed their Retrospective wishes about donation during their study Study Baseline lifetime and consent was obtained in period: Measurements: 18 of them. Last Not mentioned quarter of 2007

Setting: Sweden Additional comments: Reference: Moller, C, Welin, A, Henriksson, BA, Rydvall, A, Karud, K, Nolin, T, Brorson, I, Nilsson, L, Lundberg, D, Swedish Council for Organ and Tissue Donation National survey of potential heart beating solid organ donors in Sweden. Transplantation Proceedings 2009; 41: 729-31.

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Title: Improved organ procurement through implementation of evidence-based practice Level of evidence Patient population/characteristics Selection/inclusion criteria Intervention Comparison Follow-up Outcome and results ID: 96 Describes the effect of the introduction of the US Organ Donation Breakthrough Collaborative. As part of this, all ICU patients screened daily for organ donation clinical triggers for referral

Study type: Results showed Observational 2004 2005 P value Conversion rate 50% 80% 0.025 Authors: Bair et al. (2006) Referral rate 98% 99% n.s. Timely notification 90% 94% n.s. Appropriate requester 89% 87% n.s.

However, this was a hugely complex intervention, so it is not possible to attribute this to the use of clinical triggers alone. Additional comments: Not able to isolate the effect of clinical triggers. Limited number of data points. Reference: H. A. Bair, P. Sills, K. Schumacher, P. J. Bendick, R. J. Janczyk, and G. A. Howells. Improved organ procurement through implementation of evidence-based practice. Journal of Trauma Nursing 13 (4):183-185, 2006.

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Title: US organ donation breakthrough collaborative increases organ donation Level of Patient population/ characteristics Selection/inclusion criteria Intervention Comparison Follow-up Outcome and results Evidence ID: 61 Describes the effect of a whole programme to improve the organ donation system (US Organ Donation Breakthrough Collaborative). Part of the ‘formal concerted effort’ was teaching hospital staff clinical triggers for referral (GCS of 5) Study type: Observational Results showed that ‘The number of organ donors in Collaborative hospitals increased 14.1% in the first year, a 70% greater increase than the 8.3% increase experienced by non- Authors: Collaborative hospitals. Moreover, the increased organ recovery continued into the post-Collaborative periods. Between October 2003 and September 2006, Shafer et al. the number of total US organ donors increased 22.5%, an increase 4-fold greater than the 5.5% increase measured over the same number of years in the (2008) immediate pre-Collaborative period. The study did not involve a randomised design, but time-series analysis using statistical process control charts shows a highly significant discontinuity in the rate of increase in participating hospitals concurrent with the Collaborative program, and strongly suggests that the activities of the Collaborative were a major contributor to this increase.’ However, this was a hugely complex intervention, so it is not possible to attribute this to the use of clinical triggers alone. The authors did note that rapid testing adaptation and replication of successful practices were key to the success and the example cited was that of the use of clinical triggers. ‘OPOs had long known that an early, timely notification before brain death was associated with higher rates of donation. Physicians and nurses would often resist or fail to see the importance of the timing of referrals. Learning from other teams the clinical status of the patient that was used to prompt or ‘trigger’ a referral led to early collaboration between OPO staff and hospital staff in any number of process measures measured in donation.’ Additional comments: Not able to isolate the effect of clinical triggers. Although not RCT, high quality time series study, with good number of data points. Reference: T. J. Shafer, D. Wagner, J. Chessare, M. W. Schall, V. McBride, F. A. Zampiello, J. Perdue, K. O'Connor, M. J. Lin, and J. Burdick. US organ donation breakthrough collaborative increases organ donation. Critical Care Nursing Quarterly 31 (3):190-210, 2008.

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Title: Implementation of an intervention plan designed to optimise donor referral in a donor hospital network. Study type No. of people Patient characteristics Methods Results ID: Study group: Inclusion /Exclusion The purpose of this study was to measure the impact of an intervention The number of potential donors increased by 114 Not mentioned (study group): plan designed to optimise the donor detection process and donor 27.46 %( 324 in period 1 vs. 413 in period 2, referral patterns. p < 0.02). Author: Control group: Not mentioned Van gelder N/A A multiple point plan was designed on the basis of 3 essential equal The number of effective donors increased by et al. Characteristics of pillars: 30.86% (230 vs. 301, p < 0.05) from period 1 (2006) Study period: cases: to period 2. Jan 1996 to 1. Information on donation criteria Study type: Dec 2003 Not mentioned 2. Facilitation of the donor procedure to reduce workload in the donor The number of donor hospitals per year Observational centre increased by 37% (16 in period 1 vs. 22 in study Setting: Baseline 3. Communication between the donor centre and the transplant centre period 2, p < 0.02). Belgium measurements: to increase involvement of the donor teams in the transplant NA procedures.

Information on donation criteria

Clinical pathways brain death Clinical pathways donor management Clinical pathways organisational aspects of the procedure Donor manual (protocol) electronically available Yearly donor symposia concentrating on donor related issues Newsletter every 6 months with donor related subjects.

Period 1 was from Jan 1996 to Dec 1999 where the above protocol did not exist.

Period 2 was from Jan 2000 to Dec 2003, after implementation of the new protocol. Additional comments: This was a hugely complex intervention, so it is not possible to attribute this to the use of clinical triggers alone. Reference: Van, GF, Van, HD, de, RJ, Monbaliu, D, Aerts, R, Coosemans, W, Daenen, W, Pirenne, J Implementation of an intervention plan designed to optimise donor referral in a donor hospital network. Progress in Transplantation 2006; 16: 46-51.

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Title: Increasing organ recovery from level I trauma centers: the in-house coordinator intervention. Study type No. of people Patient Methods Results characteristics ID: Study group: Inclusion The purpose of this study was to evaluate whether OPO Service area comparison 143 Not mentioned /Exclusion (study placement of OPO staff in Level I trauma centers (LITC) group): with large donor potential, to provide case management as Total referrals increased 26% in the project IHC LITCs vs. Author: Control group: well as donation system development, would result in a 14% in the comparison hospitals. Shafer N/A Not mentioned significant increase in organ donation, particularly among et al. members of minority groups. Potential donors increased 4% in IHC LITCs. (2004) Study period: Characteristics of 1999 to 2002 cases: Protocols were developed that outlined the role and Despite the fact that the project IHC LITCs had a higher Study type: activities of the IHC in 5 critical areas: minority population than the comparison hospitals, the Observational Setting: Age of donors- consent rate was higher (55% vs. 44%) at IHC LITCs. The study 8 LITCs in New 1month to 18 Creating a positive environment for donation within the number of no consents decreased by 4% in the IHC LITCs York, Los years institution, providing support for potential donors families, despite the fact that the number of potential donors Angeles, 27 boys obtaining consent, evaluating and managing donors, and increased 4%. Houston, and 6 girls evaluating the process. Seattle. The consent and conversion rates in all ethnic groups were Baseline higher in the project IHC LITCs than in the comparison non- Measurements: IHC centers. Not mentioned National Comparison

Total referrals increased 26% in the IHC LITCs compared with 12% in the comparison LITCs.

Potential donors increased in the 4% in the IHC LITCs vs. a 2% decrease in the comparison LITC.

In the IHC LITCs the consent rate increased 13% vs. unchanged in the comparison group, no consents decreased 4% vs. 2% increase in comparison hospitals, the conversion rate increased 22% vs.2% increase, and the number of organs increased 26% vs. unchanged in the number of organs in comparison hospitals. Additional comments: This was a hugely complex intervention, so it is not possible to attribute this to the use of clinical triggers alone. Reference: Shafer, TJ, Ehrle, RN, Davis, KD, Durand, RE, Holtzman, SM, Van Buren, CT, Crafts, NJ, Decker, PJ Increasing organ recovery from level I trauma centers: the in-house coordinator intervention. Progress in Transplantation 2004; 14: 250-263.

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Title: Organ procurement 1999–2000: how is Hawaii doing? Organ donation in Hawaii: impact of the final rule Level of Patient population/ Selection/Inclusion criteria Intervention Comparison Follow- Outcome and Results Evidence characteristics up ID: 188 and Total no. of Definition of potential donors: Final Rule specified that all Pre- 12 Results were 182 deaths: hospitals notify OPOs of all deaths introduction of months brain dead Process Number and imminent deaths to maintain Final Rule 4679 (in 1999) and 70 years or younger variable 1999 2000 4730 (in 2000) eligibility for reimbursement Date: 1999 Study type: no evidence of HIV, Identification Date: 2000 Observational cancer, life-threatening Potential donors Setting: 60 66 transmissible disease at identified Authors: 17 major acute time of death Total potential Higashiwaga et care hospitals in 75 69 donors al. (2001) Hawaii Identification Higashiwaga et 80% 83% al. (2002) rate Referral Potential donors 40 56 referred Total potential 75 79 donors Referral rate 53% 70% Consent Potential donor family 48 64 approached Consent for 28 33 donation given Consent rate 58% 52%

Additional comments: Retrospective chart review. Reference: K. H. Higashigawa, C. Carroll, and L. L. Wong. Organ procurement 1999-2000: how is Hawaii doing? Hawaii Medical Journal 60 (12):314- 317, 2001. K. H. Higashigawa, C. Carroll, L. L. Wong, and L. M. Wong. Organ donation in Hawaii: impact of the final rule. Clinical Transplantation 16 (3):180-184, 2002.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 116 of 202 Title: Impact of a Bereavement and Donation Service incorporating mandatory 'required referral' on organ donation rates: a model for the implementation of the Organ Donation Taskforce's recommendations Level of Patient Selection/Inclusion Intervention Comparison Follow- Outcome and Results Evidence Population/ criteria up Characteristics ID: 28 Setting: Potential organ Required referral Standard practice 12 Results were Single NHS Trust donors Implemented through an before introduction months 2006–7 2007–8 of required referral in UK addendum to the Liverpool Number Non- Non- Study type: Heart Heart Care of the Dying pathway Date: 2006–7 heart heart Observational beating beating documentation beating beating donors donors Authors: Date: 2007-8 donors donors Murphy et al. Referred 2 1 7 31 (2009) Accepted 1 1 6 7 [NOTE: read off graph in published paper] Additional comments: Prospective study. Although attributes the increases to required referral, was part of a wider intervention. Most changes occurred before required referral, but not clear when a controlled non-heart beating donation programme was introduced and how this may have impacted on the results. Reference: F. Murphy, D. Cochran, and S. Thornton. Impact of a Bereavement and Donation Service incorporating mandatory 'required referral' on organ donation rates: a model for the implementation of the Organ Donation Taskforce's recommendations. Anaesthesia 64 (8):822-828, 2009.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 117 of 202 Title: Concentrated professional education to implement routine referral legislation increases organ donation Level of Patient Population/ Selection/Inclusion Intervention Comparison Follow- Outcome and results Evidence Characteristics criteria up ID: 239 Setting: Potential organ Routine referral Pre-introduction 24 Results were 136 hospitals in a donors Required due to legislation, and of routine months Increase 1994 1996 Study type: transplant implemented through professional referral (%) Observational programme in the educational initiatives, provision of Referrals 528 824 56 US sample hospital policies, reallocation Authors: of resources Medically Robertson et al suitable 342 427 25 (1998) referrals Donors 175 217 24

Additional comments: Limited number of data points. Not clear if attributable to routine referral alone as part of complex educational initiative. Reference: H V. M. Robertson, G. D. George, P. S. Gedrich, R. D. Hasz, R. A. Kochik, and H. M. Nathan. Concentrated professional education to implement routine referral legislation increases organ donation. Transplantation Proceedings 30 (1):214-216, 1998.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 118 of 202 Title: Texas non-donor-hospital project: a program to increase organ donation in community and rural hospitals Level of Patient Population/ Selection/Inclusion criteria Intervention Comparison Follow- Outcome and Results Evidence Characteristics up ID: 226 Setting: Non-donor hospitals: Placement of in- Pre- 24 Results were 20 non-donor > 100 beds, house coordinators introduction months . 1991- 1995- Increase practice hospitals in US regional or community centres, Establishment of 3 7 (%) Study type: routine notification Date: 1991-3 Observational had ICUs, operating rooms, Organ Free telephone 22 121 450 staff neurologists and an referrals service Authors: anaesthesiologist Hospitals Shafer et al In-service training making community based providing 13 19 46 (1998) services to local residents Date: 1995-7 organ referrals Organ 2.67 10 275 donors Hospitals with at 3 5 67 least 1 donor Organs 8.01 33 312 recovered

Additional comments: Limited number of data points. Complex intervention, so not able to attribute changes to single factor. Introduction into non-donor hospitals, so not able to estimated impact in hospitals with existing donor programmes. Reference: T. J. Shafer, R. Durand, M. J. Hueneke, W. S. Wolff, K. D. Davis, R. N. Ehrle, C. T. Van Buren, J. P. Orlowski, D. H. Reyes, R. T. Gruenenfelder, and C. K. White. Texas non-donor-hospital project: a program to increase organ donation in community and rural hospitals. Journal of Transplant Coordination 8 (3):146-152, 1998.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 119 of 202 Title: US organ donation breakthrough collaborative increases organ donation Level of Patient Population/ Characteristics Selection/Inclusion criteria Intervention Comparison Follow-up Outcome and Results Evidence ID: 61 Describes the effect of a whole programme to improve the organ donation system (US Organ Donation Breakthrough Collaborative). Part of the ‘formal’ concerted effort’ was establishment of a system wide commitment to ‘unconditionally identify all opportunities for donation.’ Study type: Observational Results showed that ‘The number of organ donors in Collaborative hospitals increased 14.1% in the first year, a 70% greater increase than the 8.3% increase experienced by non- Authors: Collaborative hospitals. Moreover, the increased organ recovery continued into the post-Collaborative periods. Between October 2003 and September 2006, Shafer et al. the number of total US organ donors increased 22.5%, an increase 4-fold greater than the 5.5% increase measured over the same number of years in the (2008) immediate pre-Collaborative period. The study did not involve a randomised design, but time-series analysis using statistical process control charts shows a highly significant discontinuity in the rate of increase in participating hospitals concurrent with the Collaborative program, and strongly suggests that the activities of the Collaborative were a major contributor to this increase.’ However, this was a hugely complex intervention, so it is not possible to attribute this to the use of clinical triggers alone. Additional comments: Not able to isolate the effect of required referral. Although not RCT, high quality time series study, with good number of data points. Reference: T. J. Shafer, D. Wagner, J. Chessare, M. W. Schall, V. McBride, F. A. Zampiello, J. Perdue, K. O'Connor, M. J. Lin, and J. Burdick. US organ donation breakthrough collaborative increases organ donation. Critical Care Nursing Quarterly 31 (3):190-210, 2008.

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Title: Organ donation rates in a neurosurgical intensive care unit. Study type No. of Patient Methods Results people characteristics ID: Study Inclusion /Exclusion The objective of the study was to analyse donation Of the 98 eligible donors identified by the OPO, consent was 172 group: (study group): rates in a busy NICU in which doctors and nurses obtained and organs were recovered in 72 cases, yielding a Not work closely with the local OPO. successful organ procurement rate of 73.5%. Author: mentioned Not mentioned Once declaration of death is confirmed, the OPO is Dickerson given early notification of all potential organ donors at The in-house OPO coordinator was called before the et al. Control Characteristics of BGTH. confirmatory cerebral radionuclide study was performed. (2002) group: cases: N/A An OPO coordinator is available in house 24 hours a Also the early notification gave the OPO coordinator sufficient Study type: Not mentioned day, and this person determines the medical time to locate next of kin and to begin investigating the medical Retrospective Study suitability of potential donors. suitability of the potential donor. study period: Baseline 1996 to Measurements: The OPO coordinators also receive specialised 1999 Not mentioned training in request techniques.

Setting: BGTH, Houston Additional comments: Reference: Dickerson, J, Valadka, AB, Levert, T, Davis, K, Kurian, M, Robertson, CS Organ donation rates in a neurosurgical intensive care unit. Journal of Neurosurgery 2002; 97: 811-14.

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Title: A system’s approach to improve organ donation. Study type No. of Patient Methods Results people characteristics ID: Study Inclusion /Exclusion The objective of the study was to take cues from the National Organ Donation Improvements were moderate. The 24 group: (study group): Breakthrough Collaborative overarching principles and best practices and spread overall system conversion rate Not these principles and practices through existing pathways within NYPHS (New improved by 42% during the first Author: mentioned Not mentioned York-Presbyterian Healthcare system). 6 months. Graham et al. Control Characteristics of One of the key principles was to have in-house OPOs. The system wide consent rate (2009) group: cases: increased by 30% over the baseline N/A year. Study type: Not mentioned Retrospective Study The overall number of organs per study period: Baseline donor was essentially unchanged from Not Measurements: the baseline year. mentioned Not mentioned

Setting: USA Additional comments: Reference: Graham, JM, Sabeta, ME, Cooke, JT, Berg, ER, Osten, WM A system's approach to improve organ donation. Progress in Transplantation 2009; 19: 216-20.

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Title: A continuous quality improvement process to increase organ and tissue donation. Study type No. of Patient Methods Results people characteristics ID: Study group: Inclusion The objective of the study was to outline the CQI (continuous quality With implementation of the CQI process, referrals 252 Not /Exclusion(study improvement) process and compare the number of organ donor for organ and tissue donors during the 10 month mentioned group): referrals with that of LifeShare of the Carolinas at the time of study increased from 49/90 (54%) in March 1994 to Author: implementation and 10 months after the implementation of the CQI 105/107 (98%) in December 1994. Burris Control Not mentioned process. et al. group: Organ donors increased from 15 to 27 (80%). (1996) N/A Characteristics of An important part of this process was to have in-house OPO cases: coordinators and have routine referrals. Study type: Study Retrospective period: Not mentioned study Mar 1994 to Dec 1994 Baseline Measurements: Setting: Not mentioned USA Additional comments: Reference: Burris, GW, Jacobs, AJ A continuous quality improvement process to increase organ and tissue donation. Journal of Transplant Coordination 1996; 6: 88-92.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 123 of 202 Supporting evidence Title: Religious attitudes regarding organ donation. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion /Exclusion A preliminary survey designed to N/A 98% of chaplains and clergy responded they were 1719 group: (study group): ascertain beliefs held by religious very comfortable with discussing organ donation. 183 leaders was designed. They also said they would feel comfortable Author: responses Not mentioned counselling a family about organ donation. Gallagher (1996) Control Characteristics of 80% of chaplains and 54% of clergy answered that group: cases: their congregants sought their professional opinion Study type: N/A Not mentioned about organ donation. Retrospective study Study Baseline All respondents believed that organ donation was not period: Measurements: a sin and respondents also agreed that religious Not Not mentioned beliefs supported their feelings about organ donation. mentioned

Setting: USA

Additional comments: Reference: Gallagher, C Religious attitudes regarding organ donation. Journal of Transplant Coordination 1996; 6: 186-91.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 124 of 202 Review Question 2: What structures and processes are appropriate and effective for obtaining consent from families, relatives and legal guardians of potential DBD and DCD donors? Title: Effect of ‘collaborative requesting’ on consent rate for organ donation: randomised controlled trial (ACRE trial) Level of Patient Population/ Selection/Inclusion Intervention Comparison Follow- Outcome and Results Evidence Characteristics criteria up ID: 896 Total no. of Inclusion: Relatives approached Relatives NA Table 1: Consent rates for organ donation patients: Participants were the by clinical team and a approached by Baseline = 317 relatives of patients donor transplant the clinical team All (n = Routine Collaborative Study Excluded- 116 declared dead by criteria coordinator alone (routine 201) request request type: Collaborative for brain stem death or (collaborative request) request) when a (n = 101) (n =100) RCT request group- 101 awaiting BSD testing who when a request for request for Consent to 119 (59) 62 57 Routine request were to be approached organ donation was organ donation organ Authors: group- 100 regarding organ made. was made. donation Young et donation. (%) al. (2009) They were allowed to Any solid 102 (51.7) 57(56) 45 (45) Baseline Exclusion: decide whether to organ characteristics: request organ retrieved Excluded units with in donation during the (% of all There were no house donor transplant interview when the patients) differences in the coordinators and a results of the BSD Per 140 73 67 characteristics of collaborative requesting tests were discussed protocol donors between rate over 50% when the or whether to request Consent to 89 (64) 44 (60) 45 (67) groups, and the study started. organ donation in a organ relatives were subsequent interview donation matched, (‘decoupling’ the (% per request). protocol Setting: patients) 79 general, Any solid 76 (54) 39 (53) 37(55) neuroscience, and organ paediatric intensive retrieved care units in UK. (% per protocol patients)

ITT analysis

OR 57/62 = 0.83 (95% CI 0.47 to 1.46) Adjusted OR

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There was no difference in the rates between groups with the risk adjusted ratio of the odds of consent in the collaborative requesting group relative to routine group was 0.80 (95% CI- 0.43 to 1.53, p = 0.49)

Per protocol analysis (not mentioned in initial methodology)

The risk adjusted ration of the odds of consent was 1.47 (95% CI- 0.67 to 3.20, p = 0.33)

Any solid organ retrieved from all patients (ITT)

OR- 0.63 (95% CI- 0.36 to 1.10)

Any solid organ retrieved from patients who consented (ITT)

OR- 0.81 (95% CI- 0.44 to 1.50)

Consent was more likely if the patient was white (8.43 for white vs. non white, p< 0.001), female (0.60 for male vs. female, p = 0.12), and in the 25–34 range (0.85 for 25–34 vs. > 60 years, p = 0.12).

There was a slightly lower conversion rate (number of donors from whom solid organs were actually retrieved as a proportion of donors in whom consent for donation had been obtained) in the collaborative requesting group compared with the routine requesting group (OR 79/92 = 0.86, 95% CI 0.74 to 1, p = 0.043)

Additional comments: Randomisation was performed (telephone based). Blinding not performed. Power calculation used. Allocation concealment not mentioned. Confounding mentioned (adjusted for age group of patients, ethnicity and sex). Patients lost to follow up and excluded after randomisation was mentioned. All parameters were analysed as intention to treat. Reference: Young, D, Danbury, C, Barber, V, Collett, D, Jenkins, B, Morgan, K, Morgan, L, Poppitt, E, Richards, S, Edwards, S, Patel, S Effect of "collaborative requesting" on consent rate for organ donation: Randomised controlled trial (ACRE trial). BMJ 2009; 339: 899-901.

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Title: A qualitative examination of the needs of families faced with the option of organ donation. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion The objective was to examine donor and N/A Contextual 234 98 potential /Exclusion(study group): non-donor family members’ perceived Staff and others present participants needs for support while in the hospital Author: 50 donor Eligible legal next of kin intensive care setting and to gain an in- The presence of and interaction with nursing Jacoby et family who consented or depth understanding of specific support staff were strongly valued by both donor and al (2005) 48 non-donor refused donation of considerations on the basis of a non-donor family members; satisfaction with family their loved one’s theoretical framework. nurses’ behaviors and care was expressed by Study type: 33/50 refused organs. all. Qualitative in donor group The research questions were: study 42/48 refused Characteristics of They also agreed that treating physicians (interviews) in non-donor cases: 1. How do donor and non-donor families tended not to be sufficiently available to them group Age range- 31-65 years describe and interpret the and provided inadequate continuity in care. 11 finally (mean-43 yrs) communication and behaviors of people participated they interacted with during the donation Comments in both groups about medical staff from donor Baseline process and how do these descriptions varied from ‘cold,’ ‘distant,’ and ‘unavailable,’ group Measurements: differ? to ‘caring,’ and ‘very competent.’ 5 from non Not mentioned donor group 2. What can we learn from families’ Timing of approach accounts of their perceived need for Control group: support in relation to their donation Families in the non-donor group felt they had N/A decision and how do the 2 groups differ not been adequately prepared for the request in this respect? for organ donation. Study period: July 1998 to 3. What are the implications for care and They also felt they had not been clearly Dec. 2000 interventions that would effectively informed that their loved one was brain dead address families’ perceived needs for before being approached about organ Setting: support? donation. 3 sites in New York In contrast, donor families depicted the timing of the approach ‘as good as could have been’ and no one described problems with the manner of the approach by staff members.

Being given the time and opportunity to spend time with their loved one and to ‘say goodbye’

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 127 of 202 was a recurring theme among donor families.

Behavioral Quality of care

A common need in both groups was compassionate care of their loved one, and for their loved one to be treated with dignity and respect.

Participants expressed a desire to be listened to and to be understood and to have staff members just ‘be there’ for them.

Also, both groups with respect to care was the need to receive information that was understandable as well as prompt, accurate, in-depth, and consistent about their loved one’s condition.

Continuity of medical staff was another common desire expressed among both groups.

The donation approach and decision making process

Family members considered the tone and pace of the information about organ donation to be critical.

Non-donor families tended to report that the information was conveyed in a rushed manner and felt their decision had to be made too quickly.

Donor families expressed similar concerns and felt that it was important not to feel pressure in arriving at a decision about donation.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 128 of 202 Examples: ‘I had a fear of giving up too quickly,’ ‘We had the feeling the physicians wished we would give up now so somebody can stop waiting.’

Tone, as expressed by both groups, referred to information being conveyed with empathy, concern, and consideration for their feeling. Examples: ‘you want to hear the truth, but there is a way to deliver the truth too,’ sitting outside the room like a hawk.’

Informational Understanding of information received

Brain death was a difficult concept to understand for both groups.

Primary sources of information

Families preferred to interact with a single physician and as a cognitive need to the degree that they felt information about the status of their loved one ought to have been consistent from physician to physician.

Informational support needs

Both groups commonly recounted the perception that physicians did not explain information adequately or sufficiently.

Family members said it would have been valuable to have physicians check their understanding of the information they were given.

Participants in both groups commented on the insensitive manner in which information often was conveyed to them.

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Many would have liked information about organ donation process in its entirety.

Emotional Emotional support needs

Participants indicated that emotional support should be provided through sensitive and clear explanations of brain death, complex medical information, the purpose of particular tests, and confirmation of their understanding of their loved one’s condition.

Participants stated that nursing staff were also important sources of emotional support.

Environmental

The need for privacy during donation discussion was almost universally seen as critically important. Many participants in both groups commented on the uncomfortable and unsuitable spaces in which such discussions had to take place.

The idea of the ‘all-in-one’ birthing room concept was mentioned as beneficial for families considering the donation option, affording the family a comfortable place where they could continuously be with their loved one. Good lighting, comfortable furniture, and music were some specific ideas proposed.

Spiritual

Faith and spiritual support was important to nearly all donor families members but less so to non-donor group participants.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 130 of 202 In some cases, hospital clergy was present, while in others, members of the families’ own religious communities were called.

Additional comments: Reference: Jacoby, LH, Breitkopf, CR, Pease, EA A qualitative examination of the needs of families faced with the option of organ donation. DCCN - Dimensions of Critical Care Nursing 2005; 24: 183-89.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 131 of 202 Title: Donor and non-donor families' accounts of communication and relations with healthcare professionals. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The wider research objective was N/A Respondents’ understanding of Brain-Death Tests 290 group: /Exclusion (study to conduct a sociological Donor group): investigation into the All respondents reported that 2 different healthcare Author: families-19 experiences, attitudes, and belief professionals carried out the tests. Most donor and non- Haddow (2004) Non-donor Not mentioned systems of donor and non-donor donor next of kin claimed that they were unaware of what families-4 families. the procedures involved (n = 18, 78%). Study type: Characteristics of Qualitative Control cases: Semi structured interviews over a The impact of time retrospective group: Not mentioned 2-year period was conducted in. study N/A The interviews were conducted at An important factor aiding understanding of the brain death Baseline a time and place that suited the diagnosis was said to be the availability of time. Study Measurements: respondents. period: Not mentioned For example: A donor spouse claimed she was unaware Not her husband was dead when asked for her lack of mentioned objection to remove organs: "[I thought], 'Yes, I'll sign the kidney donation form and if anything happens, if he dies, Setting: they can have his kidneys.' I didn't realise that it set the Scotland whole process in motion."

Brain Death: The Role of Healthcare Professional Communication

Direct information

Allowing an optimum amount of time, clear information was also alluded to as being crucial during the initial stages of diagnosis. The majority of respondents in both groups said healthcare professionals mentioned the term brain stem death.

There is a requirement for the language to be understandable to the lay person, free from medical jargon and containing concepts familiar to the respondent.

Tacit Feeling Displayed by Healthcare Professionals

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 132 of 202 Essentially, both donor and non-donor relatives searched for, assessed, interpreted, and examined available information, directly provided or otherwise, enabling them to make their own judgment regarding the potential outcome for the patient.

Organ request

Most respondents said that a consultant had made the request following the results of the brain-death tests, generally with some degree of privacy, although 1 donor family complained it was made in a public place.

Also, because transplant coordinators did not wear a uniform, donor families mentioned it was easier to speak to them.

Respect for deceased’s body

Inappropriate usage of words like "harvesting" caused the next of kin some anxiety. In one case, treating the deceased as a resource for organs, along with an assumption that healthcare-professionals could "presume" donation was reported as highly distressing.

For donor relatives, issues arose regarding a discernible moment of death, because they were not present when mechanical ventilation was removed.

Follow-up care

A third of donor respondents agreed that follow-up care might be generally beneficial, because it allowed them the opportunity to ask questions and was said to make the donation seem more sincere and personal. Respondents who had received a home visit articulated this thought.

Conversely, responses from other donor respondents who had not received a home visit suggested they could not see what they would gain from such a visit, although this

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 133 of 202 does not subsequently imply that no support should be offered.

Additional comments: A warning regarding the bias nature of the sample toward donor families might be noted and that "saturation" was not reached with the non-donor families. Comparisons are therefore made with other research conducted in the area. Equally, given the scope of this paper, the discussion does not address why donor and non-donor families refused or agreed to donation. Reference: Haddow, G Donor and nondonor families' accounts of communication and relations with healthcare professionals. Progress in Transplantation 2004; 14: 41-48.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 134 of 202 Title: Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aim was to explore how N/A Several physicians stressed the importance of "making 199 20 relatives /Exclusion (study relatives and physicians everything right when determining death." "There must be no (donors and group): understood cases where organ question at all about it." Author: non-donors) donation had been requested and Sanner 25 physicians Not mentioned what factors were salient for the Semantic obscurity et al. decision on donation. (2007) Control Characteristics of There was some confusion concerning terminology and group: cases: Relatives were mostly interviewed semantics, which was demonstrated by both physicians and Study type: N/A in their homes, but in some cases relatives. The terms used by professionals were adopted by Qualitative Not mentioned in our offices. Physicians were relatives. They said for instance mostly that the patient "was study Study period: either interviewed by telephone or declared dead" or "was declared brain dead" instead of "had Not Baseline in their offices. died" or "was dead." Also, many physicians alternated mentioned Measurements: between the terms brain dead and dead. The most difficult Not mentioned An open interview method was act to denominate was what happened when the ventilator Setting: chosen to allow informants to was removed. Sweden speak freely about their experiences, although Conflicts in task of procuring organs predetermined issues were also covered. More than half the physicians found the request for organ donation stressful and demanding determination, concentra- tion, and timing. They under-scored the importance of relatives being convinced that everything was done to save the patient in the first place and not to procure organs.

Accepting or declining request

Donation

In 4 cases, relatives at first impulsively declined the request, initially reacting with uneasiness and felt too exhausted to make a decision. However, the physicians gave time for discussion, gently pointed out the benefits of a donation, and introduced the perspective of recipients. The initial uneasiness subsided when relatives had time to start cognitive operations and consider rational and altruistic ideas in their deliberations. They were also encouraged to

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talk with other close kin.

Non donation

In one case, the closest relative did not want the deceased's organs to live on in strangers while the rest of his body was buried. The physician did not intervene in the family conversation.

In another case, the adult children were convinced that all organs of the deceased were unsuitable as transplants because the deceased was old and ill. The physician had not been successful in informing the family about possible benefits of the donation and what organs and tissue could be useful.

The relative thought it awful to cut into the deceased’s body after death. The conversation with the physician had been conducted solely by telephone.

The relative had no opportunity to discuss the issue with other family members. She was uncertain of the deceased's opinion and thought it difficult to "decide for him." She also felt a little uneasy at the thought of having him cut up. The physician said that he regarded the informant as an old, fragile lady that should not be pressed further in this issue.

In 2 cases, no relatives were found but the physician thought that relatives were in shock and not capable of fully under- standing information. His impression was that the family did not want the body to be cut into. Additional comments: Reference: Sanner, MA Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Journal of Critical Care 2007; 22: 296-304.

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Title: The instability of organ donation decisions by next-of-kin and factors that predict it. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aims were to examine the N/A Decision instability was more likely when the 72 285 next-of-kin /Exclusion(study instability of organ donation deceased had not previously discussed organ 147-donors group): decisions made by next-of-kin and donation with the next-of-kin (p = 0.01) Author: 138-non- to identify factors that predict Rodrigue et al. donors Not mentioned decision instability among non- Next-of-kin donors were more likely to consent to (2008) donor next-of-kin. donation when the person who first mentioned Each Characteristics of donation at the time of their loved one’s death was a Study type: participant was cases: Semi-structured interviews were non OPO (organ procurement organization) Retrospective paid $75.00 done within 4 weeks of the professional, such as physician, nurse, clergy, or study Age: 49.3±13.2 yrs donation decision. social worker (p = 0.01). Control group: 52% registered N/A organ donors Also when they perceived the timing of donation Spouse-36% discussion to be poor (p = 0.001). Study period: Parent-26% Jul 2001- Feb Adult child-21% Were not told of their loved one’s death before the 2004 Sibling- 10% first mention of donation (p = 0.0001) Other-7% Setting: Did not feel they were given enough time to discuss Gainesville, Baseline their donation decision with others (p = 0.006). Florida Measurements: NA These variables were statistically significant predictors of decision instability among next-of-kin non-donors in a logistic regression model. Additional comments:

Reference: Rodrigue, JR, Cornell, DL, Howard, RJ The instability of organ donation decisions by next-of-kin and factors that predict it. American Journal of Transplantation 2008; 8: 2661-67.

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Title: The stability of family decisions to consent or refuse organ donation: would you do it again? Study type No. of Prevalence/ Patient characteristics Methods Reference Results people incidence standard ID: Study group: N/A Inclusion /Exclusion(study The aim was to examine the N/A Demographic factors 477 225 group): psychological consequences of individuals consenting or refusing donation of African-Americans were less likely to donate Author: 159- Families who had actual the organs or tissue of a dying than Caucasians (p < 0.001) Burroughs et donating potential, medically family member. al. (1998) families acceptable donor family Individuals with more formal education were 66-non members. Participants were interviewed more likely to donate than individuals with less Study type: donating using the same phone survey formal education (p < 0.001) Retrospective families Tissue donors were not instrument. study included. Individuals who were married were more Control Four groups were identified: satisfied with their decision than individuals who group: Characteristics of cases: were single, divorced, or widowed (p < 0.01) N/A Group1- nondonors who would Mean age- 48.01 years make the same decision again Past behaviors of the donor family Study (SD-14.63) Group2- nondonors who would not period: 78-men make the same decision again The act of signing a donor card, discussing 1988 to 157-women Group 3- donors who would make organ donation, and contributing money to 1992 the same decision again charities, were all associated with the decision Baseline Measurements: Group 4- donors who would not to donate organs or tissues (p = 0.01). Setting: Not applicable. make the same decision again USA Medical/Hospital factors

Satisfaction was higher whenever the donation took place in a hospital that the family typically used for family care (p < 0.01)

Families were more satisfied with their decision when the deceased died at a medical centre that they considered to highly regarded (p < 0.01)

Whenever approach was made in large university medical centre, families were less satisfied than when the request was made at a community hospital, regardless of the

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community hospital’s size (p < 0.01)

Previous knowledge about transplantation

Families who considered transplantation to be proven procedure and believed that it had a high success rate were more likely to donate than families who did not hold these beliefs (p < 0.01).

Donation was more likely if the family personally knew someone who had received an organ or tissue(p < 0.01).

Families who understood the term brain death, and who had its meaning explained were more likely to become satisfied donors (p < 0.05).

Request process

Individuals who felt pressured to donate were less likely to do so than individuals who did not feel pressured (p < 0.05)

Religion

Individuals for whom religion did not play a major role were more likely to indicate that they would now donate if given the opportunity (p < 0.01).

Donation rates were higher for individuals for whom belief in life after death did not pose a problem for donation (p < 0.01).

Individuals who attended religious services frequently were less likely to have donated and been satisfied (p < 0.05). Additional comments:

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Reference: Burroughs, TE, Hong, BA, Kappel, DF, Freedman, BK The stability of family decisions to consent or refuse organ donation: would you do it again? Psychosomatic Medicine 1998; 60: 156-62.

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Title: Trend of consents for donation by relatives of cadaveric donors in Kingdom of Saudi Arabia. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aim was to evaluate the success rates of N/A There were no significant changes 548 815 /Exclusion (study convincing the relatives of the documented brain- in the rates of success of obtaining approachable group): dead organ donors who were suitable for donation consent for donation in the male Author: families of organs to consent for donation. (41%) and female (27%) groups Shaheen et al. Not mentioned (1996) Control group: The method of approaching the family for N/A Characteristics of donation included: Study type: cases: Retrospective Study period: 689-males 1. The family was told about the diagnosis of study 1986 to 1994 126-females brain death by the treating physician or (audit) intensive care unit physician. Setting: Baseline 2. A ‘gap’ for grief was given before requesting Saudi Arabia Measurements: the consent for organ donation from them. Not applicable. This was usually 6-8 hours. 3. The convincing team showed sympathy, explained the concept of brain death in good terms, and supported their talks with explanation of the religious views about donation and brain death. Additional comments:

Reference: Shaheen, FA, al-Khader, A, Souqiyyeh, MZ, Attar, MB, Ibrahim, S, Paul, TT, al-Swailem, AR Trend of consents for donation by relatives of cadaveric donors in the Kingdom of Saudi Arabia. Transplantation Proceedings 1996; 28: 381.

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Title: Refusal of consent for organ donation: from survey to bedside. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aim was to identify reasons N/A Traditional cultural beliefs on keeping 789 435 potential organ /Exclusion(study given by family at bedside when a the body intact was the most common donors monitored group): request for donation was refused. reason for refusal (54.2%) Author: Not mentioned Yong et al. 12% expressed fear that donation (2000) Control group: would increase the sufferings of the N/A Characteristics of patient. Study type: cases: Prospective Study period: Not mentioned Uncertainty about relatives’ wishes and study 1996 to 1998 patients’ objection to donation when (survey) Baseline alive accounted for 8% Setting: Measurements: Hong Kong Hospital Not applicable. Emotional reluctance to accept death – Authority Transplant 5% Registry Lack of family consensus and family being ‘upset’ – 3%

Additional comments: Reference: Yong, BH, Cheng, B, Ho, S. Refusal of consent for organ donation: from survey to bedside. Transplantation Proceedings 2000; 32: 1563.

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Title: Factors influencing families’ consent for donation of solid organs for transplantation. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion The goals were to assess the N/A Associations of factors predating the 387 420 cases /Exclusion(study group): determinants of families’ willingness to donation decision. 238 donors donate solid organs, to describe the Author: 182 non-donors Not mentioned process and content of the Families of white patients (61.4% vs. Siminoff et al conversations surrounding the 38.6%, p < 0.001), younger patients (2001) Control group: Characteristics of donation request, and to evaluate the (p = 0.001), and male patients (62.2% vs. N/A cases: correlation between these factors and 37.8%, p = 0.007) were more likely to Study type: Not mentioned the consent rate. consent to organ donation. Retrospective Study period: study Jan 1994 to Dec Baseline Data collection was done via chart Consent was also associated with deaths (chart review 1999 Measurements: reviews, telephone interviews with due to trauma compared with non-trauma and interviews) There were no health care practitioners (HCPs) or related deaths (65.1% vs. 34.9%, Setting: differences between organ procurement organization p = 0.002). 9 trauma hospitals, participants and non (OPO) staff, and interviews with family Southwestern participants by age, for all donor-eligible deaths. No associations were found between Pennsylvania and sex, or ethnicity. consent rates and families’ educational Northeastern Ohio attainment or income.

Families who reported positive beliefs about organ donation and had prior knowledge of the patients’ wishes regarding organ donation were significantly more likely to donate.

Knowing the patient had a donor card (p < 0.001), having had an explicit discussion about donation with the patient (p = 0.02), and a belief that patient would have wanted to donate (p < 0.001) were strongly associated with consent to organ donation.

HCPs’ comfort with answering families’ questions about donation was significantly associated with organ

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donation (p < 0.001).

No association was found between the decision to donate and the hospital environmental variables or HCPs’ sociodemographic characteristics and HCPs’ attitude towards organ donation. Donation decisions and decision process variable.

Families who believed that 1 or more HCPs involved in their relatives’ care were not caring or concerned were somewhat less likely to donate (p = 0.04).

Families who were surprised to be asked about organ donation were less likely to donate than families who were not (p < 0.001).

Families who felt harassed or pressured to make a decision were also less likely to donate (p = 0.002).

HCPs correct assessment of a family’s initial reaction to the issue of organ donation was strongly associated with the donation decision.

Families who were congruent with HCPs concerning the initial reaction to the donation request were more likely to donate (p < 0.001).

Rates of consent were not different when a physician, nurse, social worker, or OPO staff member made the initial request (p = 0.30).

However, when a hospital-based HCP

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(but not a physician) broached the possibility or organ donation, followed by a meeting with an OPO staff person, the donation rate exceeded that of any other discussion pattern (p < 0.001).

Talking to an OPO staff person before being asked to make a donation decision (p < 0.001), and spending more time with an OPO staff person (p < 0.001) were both factors strongly associated with donation.

A salient feature of consent would be a family understands that the patient was indeed dead.

Certain topics such as costs of donation, the impact of donation on funeral arrangements, disfigurement of the body and assurances that the family had a choice about which organs to donate correlated with organ donation decisions (p < 0.001).

When HCPs told families they were required to ask about donation, families were less likely to donate (p = 0.002).

However, when HCPs mentioned that donation had the potential to help others, families were more likely to donate (p = 0.001).

Having more discussions about donation itself, discussing more topics of concern to the families, and having more questions answered were all associated with consent to donate (p < 0.001).

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Additional comments:

Reference: Siminoff, LA, Gordon, N, Hewlett, J, Arnold, RM Factors influencing families' consent for donation of solid organs for transplantation. JAMA 2001; 286: 71-77.

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Title: Donor Families' Attitude Toward Organ Donation. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The aim of our study was to investigate the N/A Beyond the generally defined "humanitarian" 1558 group: /Exclusion (study psychological mechanisms related to the reason for donation, there was a latent yet quite 20 families group): family's decision to consent to organ explicit longing to keep the deceased relative alive Author: donation. by identifying him or her with the patients into La Spina et al. Control Not mentioned whom the organs were transplanted. (1993) group: The research consisted of two parts: first, a N/A Characteristics of preliminary survey was carried out on 20 Noticed an increase in consent to organ removal Study type: cases: families who had given their consent to when the persistent beating of the heart was Retrospective Study Not mentioned organ removal from a relative deceased justified to the donors' relatives. Breathing study period: from 6 to 12 months previously. movement induced by artificial ventilation, body Not Baseline The second part of the research was carried temperature, and persistent heart beat are the mentioned Measurements: out by means of a questionnaire which main reasons for not accepting brain death as real Not mentioned included different areas of interest, filled in death. Setting: by one of the doctors of the 1CU medical Italy staff at the end of the clinical event, either in Refusal rate is higher in families with a low socio- case of a consent to donation or refusal. cultural level.

Additional comments: Reference: La, SF, Sedda, L, Pizzi, C, Verlato, R, Boselli, L, Candiani, A, Chiaranda, M, Frova, G, Gorgerino, F, Gravame, V, Mapelli, A, Martini, C, Pappalettera, M, Seveso, M, Sironi, PG Donor families' attitude toward organ donation. Transplantation Proceedings 1993; 25: 1699-701.

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Title: Demographic factors influencing consent for cadaver organ donation. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion To determine whether there were any factors N/A Age of donor 686 group: /Exclusion(study that influenced families to give consent for organ 566 group): donation. Families of donors aged < 10 years gave Author: potential consent more frequently than those in all Pike donors Not mentioned This retrospective study examined the records other age groups ( p= 0.02).The largest et al. (1990) referred of all cadaver donor referrals to the renal and group of donors were those between the Characteristics of cardiac transplant units. ages of 21 years and 30 years. In this group Study type: Control cases: consent was obtained in 78.5% of cases. Retrospective group: 424 males Potential organ donors were identified and study (audit) N/A 137 females certified brain dead (irreversible loss of all brain Sex of donor Mean age- 28 function) by the doctor in charge of the patient. Study years Once certified brain dead, the patient was The sex of the potential donor did not period: immediately referred to the transplant influence the decision of the family about Jan 1984 to Baseline coordinators attached to the renal and cardiac organ donation. Jun 1989 Measurements: transplant units. Not mentioned Race of donor Setting: Groote Of the 127 white families approached, 91% Schuur gave consent. Of the 189 families of mixed Hospital, race who were approached, 74% consented Cape Town. and 42% of the 50 black families who were approached for consent agreed.

These differences in consenting to organ donation were statistically significant when all the race groups were compared (p = 0.000002)

When consent from black families was compared with consent from both white and mixed families the differences remained statistically significant (p = 0.0004).

Cause of death

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There was no difference in the frequency of consent for organ donation between these groups.

Additional comments: Reference: Pike, RE, Kahn, D, Jacobson, JE Demographic factors influencing consent for cadaver organ donation. South African Medical Journal 1991; Suid-Afrikaanse: 264- 67.

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Title: Information on Relatives of Organ and Tissue Donors. A Multicenter Regional Study: Factors for Consent or Refusal. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion To assess the conditions under N/A In two thirds of the cases the family had been 554 300 interviews /Exclusion(study which relatives were informed, and informed when brain death occurred, before the group): to determine the criteria that would information about organ and tissue donation. Author: Control group: improve the rate of consent. Noury et al. N/A Brain dead The shifts dwelled on the fact that the patients (1996) patients. After patient information had been were dead (252 of 300 cases), with explanations Study period: obtained, a questionnaire was filled about cerebral death in 230 cases. Study type: Eastern France- Characteristics of in by the doctor. Retrospective Jan 1991 to Sept. cases: When the family was reticent, the rate of study 1992 200 males agreement was very low. Western France- 100 females Jul 1992 to Apr The frequency of the refusals decreased with 1993 Baseline Measurements: age, that is, 35% before 18, 28% between 19 Setting: Not mentioned and 50, and 13% after 50. Rates of agreement Eastern (8 were not influenced by sex nor by the causes of hospitals) and cerebral death. Western (9 Hospitals) France Additional comments: Reference: Noury, D, Jacob, F, Pottecher, T, Boulvard, A, Pain, L Information on relatives of organ and tissue donors. A multicenter regional study: factors for consent or refusal. Transplantation Proceedings 1996; 28: 135-36.

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Title: Barriers to Obtaining Family Consent for Potential Organ Donors. Study type No. of Prevalence/ Patient characteristics Methods Reference Results people incidence standard ID: Study N/A Inclusion /Exclusion(study The purpose of this study was to compare N/A The average time from 1143 group: group): families who declined organ donation to those declaration of brain death to 827 Who granted consent, specifically to identify approach by TOSA was 213 Author: potential All potential organ donor barriers to family consent for successful organ minutes ± 958 minutes. Brown organ referrals to TOSA (Texas organ donation. et al. (2010) donor sharing alliance) during the 4- 471 families consented to referrals year period from January 1, Information was collected from a database of all donation Study type: 2004, through December 31, potential organ donors maintained by TOSA. 356 declined donation Retrospective Control 2007, were included in the study group: analysis. Once contacted by the healthcare team about a Consent rates were lower in the N/A potential organ donor, TOSA responds Hispanic (46%) and African Characteristics of cases: immediately with a standard structure of American (33%) populations, Study Average age- 39±18 yrs approach. The approach of TOSA for potential than among Caucasian (75%) period: 467 males organ donors includes (1) an assessment of the potential donors (p < 0.001). 2004 to family; (2) collaboration with the healthcare team 2007 Baseline Measurements: regarding: family visitation with their loved one, The decline group more often Not mentioned timing of approach, a private setting for had an approach initiated Setting: discussion, assistance for the family, and independently by a healthcare USA introduction of TOSA staff to the family; (3) provider (15% vs. 8%, p = verifying family understanding of their loved 0.001). one's condition; (4) offering the opportunity for organ donation; (5) providing information and Families approached at the time answering questions regarding organ donation; of or within 1 hour of brain death (6) allowing time for the family to make a consented to organ donation in decision; and (7). The family then decides 61% of cases, but if approached whether to consent or decline organ donation. >3 hours after brain death consent rates dropped to 51% (p < 0.001).

Consent rates were significantly lower for medical (51%) patients than for trauma (67%>) patients (p < 0.001).

Similarly, older patients (aged 50 years or older) had a lower

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consent rate than younger patients (51% vs. 61%,p = 0.006).

Potential donor characteristics independently predictive of failure to consent for organ donation include:

Medical brain death {OR- 1.6 (1.2-2.4), p = 0.005} Ethnicity {OR- 5.4 (1.6-18.5), p = 0.007) Independent member of the healthcare team approach {OR- 1.9 (1.2-3.2), p = 0.01} and Aged 50 years or older {OR- 1.4 (1.0-2.0), p = 0.05}. Additional comments: Reference: Brown, CV, Foulkrod, KH, Dworaczyk, S, Thompson, K, Elliot, E, Cooper, H, Coopwood, B Barriers to obtaining family consent for potential organ donors. Journal of Trauma-Injury Infection & Critical Care 2010; 68: 447-51.

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Title: The process of organ donation and its effect on consent. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study is to N/A Multiple logistic regressions demonstrated that the best 397 827 potential /Exclusion (study identify those factors that enhance and strongest predictor of consent or refusal to donate organ donor group): or inhibit donation in a sample of was the family's initial response to the donation request, Author: referrals 23 hospitals in two states. as reported by the HCP. Siminoff 1207 individual Not mentioned et al. (2000) HCPs Each week, the medical charts of Those who expressed an initially favorable response to Characteristics of all patient deaths (both in-patient the donation request discussed more issues about Study type: Control group: cases: and emergency room) at each hos- donation than those who did not. The mean number of Prospective N/A pital were reviewed to determine total discussion items was 10.55 for families who were study Not mentioned eligibility for organ, tissue, or initially favorable toward the donation request, 5.95 items Study period: cornea donation. for undecided families, and 5.63 items for families who 1991 to 1995 Baseline were not favorably disposed to the request for donation Measurements: Interviews were conducted with (p > 0.001). Setting: Not mentioned HCPs, including physicians, 23 Hospitals in nurses, and others (generally The process of procurement was explained to 19.9% of the Pittsburgh medical social workers and clergy), families who were favorable, but to only 3.0% of the and Min- who either spoke with the family undecided, and 1.9% of the unfavorable families. neapoIis/St after the patient's death or Paul discussed donation with the family. HCPs told 62.2 and 64.4% of the undecided and unfavor- able families that they were required by law to ask about donation, but made this statement to only 49.8% of the families who responded favorably to the donation request. Undecided responses to the donation request were almost three times as likely to occur when HCPs told families they were required to ask about donation (OR = 2.71, p<0.002).

More detailed information was provided to the favorable families as compared to the other two groups concerning the effect of donation on funeral arrangements and costs. Families were 6 times as likely to be undecided when funeral arrangements were not discussed and 4 times as likely to be undecided when no assurances were provided that the funeral wouldn't be delayed as a result of donating.

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Patients of families who were initially opposed to donation were least likely to be cared for in a pediatric hospital. Lack of specificity when discussing donation was also associated with unfavorable responses to the donation request. For example, when the rules and procedures for the distribution of donated organs were not discussed, families were 11 times as likely to respond negatively to the request.

In addition, when requesters reported a general attitude of no confidence in the willingness of families to donate, their requests were more likely to evoke a response of indecision by the families (OR = 2.19, p = 0.018).

Additional comments: Reference: Siminoff, LA, Arnold, RM, Hewlett, J The process of organ donation and its effect on consent. Clinical Transplantation 2001; 15: 39-47.

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Title: Knowing Patients' Preferences about Organ Donation: Does it Make a Difference? Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion /Exclusion The purpose of this study was to examine in N/A The most frequently stated 530 420 individuals (study group): detail the impact of knowledge of a donor- reasons not to donate were eligible patient's preferences on organ donation concerns about disfigurement Author: Control group: Only patients 16 years of decisions. and burial issues (66.7%); Siminoff N/A age or older were Feeling too overwhelmed et al. (2002) included. Data collection included identification of all emotionally and surprise at Study period: Failure to request organ possible organ donor-eligible patients on the being asked to donate Study type: 1994 to 1998 donation excluded the basis of a detailed chart review of all deceased (58.3%); Retrospective family from the interview patients; audiotaped telephone interviews with The process taking too long'— study Setting: portion of this study. all health care providers (HCPs) and OPOs who either declaration of brain (survey) 9 trauma hospitals spoke with donor-eligible patients' families about death or procurement (50.0%); in southwest Characteristics of cases: organ donation and a feeling that the patient Pennsylvania and 59.44% male had "been through enough" northeast Ohio 85% white (50.0%). Mean age- 45.4 yrs (16- Less frequently stated 86) concerns were as follows: Against donation or had a prior Baseline Measurements: negative experience with Not mentioned donation or transplantation (33.3%); Not liking the HCPs/OPOs or the hospital (33.3%); The family made their own assessment about eligibility to donate and thought the patient was ineligible (25.0%); Not wanting the patient to remain on mechanical supports (25.0%); Concerns that donation would be too distressing for another family member (16.7%); and the absence of a donor card (8.3%).

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The following were significantly related to deciding to donate when adjusting for other factors:

Patient being white (p = 0.034), Patient being younger (p = 0.001), Family respondent being older (p = 0.047), Family having a middle income level compared with a higher income level (p = 0.045), Family being Protestant compared with religions other than Catholic (p = 0.035), and family considering how the patient felt about donation (p < 0.001). Families who knew the patient's wishes (p = 0.001). Additional comments: Reference: Siminoff, LA, Lawrence, RH Knowing patients' preferences about organ donation: does it make a difference? Journal of Trauma-Injury Infection & Critical Care 2002; 53: 754-60.

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Title: A Survey of Families of Brain Dead Patients: Their Experiences, Attitudes to Organ Donation and Transplantation. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion This study was designed to attempt an N/A The odds of being asked about organ donation 1527 211 brain dead /Exclusion(study examination of the experiences of a peaked in the group 30-39 years, and those who patients group): group of families of patients declared spoke English were significantly more likely to be Author: 163 brain dead, including those becoming asked (p = 0.016). Pearson questionnaires Not mentioned organ donors, those where donation et al. (1995) sent out was refused, and those not asked about Females were significantly less likely to donate 69 replied Characteristics of donation. than males (p = 0.019), donors were of Study type: 32 donor cases: caucasoid ethnic origin (p = 0.049) and English Retrospective families The study protocol required that families speaking (p = 0.007). study 21 non-donor Not mentioned be contacted first by telephone to (survey) families introduce the study and to request The initial period: Illness and treatment plan Baseline consent before questionnaires were Control group: Measurements: mailed. N/A 63% regarded the information as sufficient, most Not mentioned (83.5%) felt that the information was Study period: understandable but 36% were also confused Jan 1987 to Oct through insufficient information, the use of overly 1990 complex medical terminology, the suddenness and their distress. Setting: Westmead Thirty-six would have liked methods such as X- Hospital ICU, rays, diagrams, models or pictures used to Australia explain the patient's brain injury.

22 families admitted that they experienced some rudeness or unpleasantness from staff at some stage of the hospital care. Nurses were more likely to be officious and impatient, while doctors were judged as cold and callous.

Explanation of brain death

Twenty per cent of families felt that brain death was poorly explained.

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For seven families their distress interfered with their ability to understand what they were being told, for five the terminology was too complex, six felt that the explanation was insufficient.

Fifty-five per cent would have liked diagrams and pictures, X-rays and written material to aid understanding. The decision to donate

The decision to decline organ donation was in response to the patient's wishes, or because they did not want the patient to suffer any further dis- turbance.

When organ donation was requested

Of those asked, 14 respondents reported that they still had doubts about whether their relative "was really dead".

Of the total, 74.5% felt that they were given enough time to make a decision and 74% felt they were given enough information to make an informed choice.

Pressure by staff was felt by nine respondents (without affecting their rate of agreement). These nine however also felt they were given insufficient time or information.

After brain death

The majority 86% felt that they had been given enough time with the patient before organ retrieval or the removal of the ventilator, and that they had not been hurried to say their goodbyes (88%).

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Since the death

Of those agreeing to organ donation, 84% believed that organ donation had been helpful to the grieving process, principally because of the sense of having helped another person (14) or because they believed that their relative would have liked to have helped another (5), or that death was not just a waste (5). Additional comments: Reference: Pearson, IY, Bazeley, P, Spencer-Plane, T, Chapman, JR, Robertson, P A survey of families of brain dead patients: Their experiences, attitudes to organ donation and transplantation. Anaesthesia and Intensive Care 1995; 23: 88-95.

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Title: Organ donation and family decision-making within the Spanish donation system. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion This study analyses the N/A Reasons for refusal to consent for donation by families 577 group: /Exclusion(study variables associated with the 68 cases group): decisions made by families of Deceased's opposition to donation in life (n=6), Author: 18 potential organ donors to give Ignorance of the deceased's wishes about donation (n=5), Martinez refused to Not mentioned or deny consent for the Problems with appearance/integrity of deceased's body (n=5), et al. (2001) donate extraction of organs. Family disagreement in relation to donation (n=4), 50 Characteristics of Doubts about relative's death (n=2), Study type: donated cases: Interviews and questionnaires Complaints about medical attention (n=2), Retrospective were used. Social resentment (n=2), study Control Not mentioned Absence of main decision-makers (n=1), group: Lack of respect for deceased by hospital staff (n=1), N/A Baseline Religious problems (n=1), Measurements: Desire to take deceased's body home (n-), Study Not mentioned Distrust of organ destination (n=1), and period: Complaints about personal treatment in the hospital (n=1). May 1994 to May Opinions of transplant coordinators 1995 The position of the family on donation maintains an important Setting: relation to the deceased's expressed wishes, and the 13 deceased's wishes were more frequently respected when Spanish he/she had favored donation. hospitals There was a stronger tendency for the process to end in refusal when the deceased was a woman.

Families that maintained "good relations" among their members tended to agree to donation whilst families that maintained relations perceived as "regular or poor" were disproportionately represented among the refusals.

The data also reveal a tendency towards a greater presence of "close relatives and other people" (distant relatives, friends, etc.) in interviews resulting in concession of permission. Consent to donate was obtained in all of the consent interviews in which 3-6

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people participated, whilst the presence of "two people" tended to be linked statistically much more often to refusal to donate.

In turn, families that expressed dissatisfaction with the medical attention received or gave no opinion on it showed a greater tendency lo decline the coordinator's request; the same occurred with those families that complained about the personal treatment received, or gave no opinion on it. In contrast, those families that expressly manifested their satisfaction with these aspects tended to agree to donation. Additional comments: Reference: Martinez, JM, Lopez, JS, Martin, A, Martin, MJ, Scandroglio, B, Martin, JM Organ donation and family decision-making within the Spanish donation system. Social Science & Medicine 2001; 53: 405-21.

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Title: Family Refusal in Organ Donation: Analysis of Three Patterns. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion To evaluate the guidelines followed by the transplant N/A Notable differences in the latter 1398 group: /Exclusion(study coordinators during family interviews. two groups (refusal or 269 group): indecision) included the low Author: interviews cultural level of the family, as Frutos 248 valid Not mentioned The participants were divided into the following groups: perceived by the interviewers; et al. (2002) reports The absence of the main 21 Characteristics of Group A- acceptance of donation decision-making members of Study type: incomplete cases: Group B- refusal of donation the family (usually parents or Retrospective interviews Group C- indecision. spouse) during the first study Not mentioned interview; Control The interviews with the families of potential donors were And the attendance of a group: Baseline always performed after confirmation of brain death by greater number of people at the N/A Measurements: neurological examination and an instrument test (usually an interview. Not mentioned EEG). Two members of the transplant coordination team (a Study doctor and a nurse), as well as a doctor from the intensive Among the 146 initial period: care unit, participated in the interview. The most common interviews that authorized Jan 1995 to place was in a room near the ICU; we always tried to ensure donation (group A), all except Dec 2000 the presence of the immediate family of the deceased, having one resulted in donation, as the power of decision, with no restriction as to the number of one family changed their mind Setting: persons. If the family initially refused or were unsure, subse- prior to organ retrieval. Spain quent meetings were held if there was no objection. Of the 64 families who initially refused (group B), 13 (20%) changed their minds about donation,

And among the 38 who were initially unsure (group C) 25 (65%) finally did authorize organ recovery.

Additional comments: Reference: Frutos, MA, Ruiz, P, Requena, MV, Daga, D Family refusal in organ donation: Analysis of three patterns. Transplantation Proceedings 2002; 34: 2513-14.

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Title: Factors affecting cadaveric organ donation: A national survey of organ procurement coordinators. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion /Exclusion(study The overall purpose of the present study N/A Reasons for donations as perceived 1725 210 group): was to conduct a national study of by the OPCs questionnaires OPCs (organ procurement coordinators) Author: mailed Subject selection criteria in order to begin to validate on a large The two most common reasons for Douglas 202 returned were as follows: scale factors that affect families' donating given by families were: (1994) decisions regarding organ donation. Control group: (a) The individual was (a) The family felt that the brain-dead Study type: N/A currently employed as an A 21-item questionnaire was used as relative would have wanted his/her Retrospective OPC in the United States the data collection instrument. organs donated (known preference) study Study period: as of December 1991 and Not mentioned. (b) The OPC was a (b) The family felt that something member of the North positive would come from their loss. Setting: American Transplant The next most common reasons USA Coordinators Organizations reported by OPCs were (NATCO), and (c) The family member would somehow (c) The OPC was identified live on, and as being directly involved in (d) Donating was seen as a good thing organ donation requests in to do. the NATCO directory. Reasons for non-donations as Characteristics of cases: perceived by the OPCs

Not mentioned OPCs reported that in their experience, the most common reason for not Baseline Measurements: donating given by families was that Not mentioned families did not know if the donor would have wanted his/her organs to be donated.

Other reasons reported by OPCs were:

(a) Concern by family about disfigurement of the body after death (b) The family had a negative experience with health care personnel (c) Religious/spiritual reasons.

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(d) Fear that less than adequate medical care would be given, and (e) Fear that organs would be removed prematurely.

Most important factors that influenced families’ decisions regarding organ donation

1. "Giving the family time to accept death prior to the discussion of organ donation." 2. "How the family was treated by health care personnel." 3. "Knowledge of the loved one's wishes" was the most important factor.”

Suggestions by OPCs about what HCPs could do to facilitate the donation request experience

1. "Decouple the brain death and organ donation discussion." 2. "Ongoing communication with family members throughout the donation process." 3. 'Leave the donation requesting to OPCs." 4. "Informed, positive, and caring person request donation." 5. "Involving the OPC early on in the process." Additional comments: Reference: Douglas, S Factors affecting cadaveric organ donation: a national survey of organ procurement coordinators. Journal of Transplant Coordination 1994; 4: 96-103.

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Title: Post-mortem organ donation and grief: a study of consent, refusal and well-being in bereavement. Study No. of people Prevalence/ Patient characteristics Methods Reference Results type incidence standard ID: Study group: N/A Inclusion /Exclusion(study group): Objectives of the current N/A Information 345 183 families study were to examine the approached Inclusion criteria were that the deceased relation between In the ODC group, 75% stated they thought Author: 100 had to be less than 65 years of age, and consenting to a post- they received adequate knowledge of the Cleiren consented to died of primary brain tumor, cerebral mortem organ donation concept of brain death. et al. participate hemorrhage, or cerebral anoxia. A further procedure and subsequent (2002) 5 families criterion was that the bereaved had to be process of grief in the Although, sometimes the bereaved claimed excluded next of kin in the first degree, that is, loss bereaved. that essential information about brain death Study 95 study of a spouse, (adult) child, parent, or or the donation procedure was never given. type: sample sibling. The instrument used was Cross 36 donated an elaborate structured When asked, half of the bereaved stated sectional 23 refused Characteristics of cases: interview containing they would have appreciated a presentation survey donation precoded answering of visual material (e.g., the results of the 36 not asked Not mentioned categories as well as open EEG) to clarify the situation of the deceased. for donation questions. Baseline Measurements: Breaking the news of death and donation Control Not mentioned 3 groups were identified: request group: N/A ODC- organ donation In almost half of the cases (48%) the consent pronouncement of death and donation Study period: ODR-organ donation request were made in the same session with Not refusal the bereaved. In 19% of the cases, donation mentioned. NDR-no donation request had even been discussed preceding the death. To 18% of the ODC bereaved, it was Setting: not clear that their loved one had died at the 27 hospitals, time of the request. Netherlands Of the ODR group, 24% were dissatisfied with the way in which the donation question was posed to them. Amongst consenters (ODC) this percentage was lower (10%).

In a small minority of cases the bereaved experienced a disturbing lack of privacy at the time of death, as well as the request and decision to donate organs.

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Care and well being

The subject of dissatisfaction was commonly a lack of attention or room for the bereaved family, and an impersonal, casual, or business-like approach.

Experiences with hospital staff: some problem areas

In many cases, the bereaved reported they had not understood what was happening. They often had not had the courage to ask again for clearer info.

The use of unfamiliar technical medical terms was repeatedly mentioned.

Some bereaved also reported that the flow of information stopped as soon as they had given their response to the request: they felt superfluous and ignored afterward.

The desire to be informed about the results of the transplanted organs was strong in almost all bereaved.

Most bereaved judged medical staff to be quite friendly and benevolent. At the same time, it was clear that a number of physicians lacked time, basic social skills, and willingness to deal with the situation of the bereaved family members. The care by the nursing staff was often evaluated to be warmer and supportive. Additional comments: Reference: Cleiren, MP, Van Zoelen, AA Post-mortem organ donation and grief: a study of consent, refusal and well-being in bereavement. Death Studies 2002; 26: 837-49.

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Title: Why relatives do not donate organs for transplants: ‘sacrifice’ or ‘gift of life’? Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The aim was to N/A 6 main themes that contributed to decision making about donation 115 group: /Exclusion(study explore the were identified 26 relatives group): reasons family Author: who members declined 1. Protecting the dead body- participants did not wish to relinquish Sque declined Not mentioned organ donation. their guardianship of the body and they wished to keep it intact; for et al. donation it not to be cut up. (2007) Characteristics of Face-to-face or 2. Circumstances at the time of the death- participants had Control cases: telephone usually experienced a sudden, unexpected change in the health Study type: group: interviews were status of their relative and therefore needed time to recognize: Retrospective N/A Age-26-75 years arranged. what had happened to their relative, the seriousness of the critical cross sectional injury, that despite technological progress in medicine their qualitative study Study Baseline relative would not survive, and finally, that their relative was dead period: Measurements: based on neurological criteria even though the deceased body 2005 Not mentioned appeared viable and unscathed. 3. A lack of knowledge- some participants lacked information about Setting: the process of organ donation actually involved. 4 ICUs, UK 4. The donation discussion- concerned the timelines and sensitivity of the discussion 5. Witnessing the observable ending of life (represented by cessation of the heartbeat)- some participants needed to witness the observable ending of life 6. The expressed views towards donation of participants and the reported views of their deceased relatives, at the time of decision- making. Additional comments: Reference: Sque, M, Long, T, Payne, S, Allardyce, D Why relatives do not donate organs for transplants: 'sacrifice' or 'gift of life'? Journal of Advanced Nursing 2008; 61: 134- 44.

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Title: Identification of variables that influence brain-dead donors’ family groups regarding refusal. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion The aim was to identify the variables that N/A Strategies used by transplant 20 186 family /Exclusion(study influenced brain-dead donor family groups coordinators were: interviews group): to refuse donation. Author: Setting a place for the Sotillo Control Not mentioned A tool was designed to register all phases interview et al. group: of family interview. Asking open-ended questions (2009) N/A Characteristics of Listen actively cases: Identification of family grief Study type: Study period: Reflexive answers Retrospective 2007 Average age-27 years Donation as a way to improve descriptive study 71.11% male the spiritual value of the dead Setting: donor Venezuela Baseline Donation as a loving act for Measurements: others Not mentioned Donation as a significant act of life

Reasons for denials from families include:

Absolute denial Family disagreement Uncertainty about the destination of donated organs Fears about deformation of the donor’s body No acceptance of brain death Additional comments: Reference: Sotillo, E, Montoya, E, Martinez, V, Paz, G, Armas, A, Liscano, C, Hernandez, G, Perez, M, Andrade, A, Villasmil, N, Mollegas, L, Hernandez, E, Milanes, CL, Rivas, P Identification of variables that influence brain-dead donors' family groups regarding refusal. Transplantation Proceedings 2009; 41: 3466-70.

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Title: Obtaining consent for organ donation in 9 NSW metropolitan hospitals. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion /Exclusion(study N/A Reasons for non-donation 138 177 potential donors group): 126 diagnosed as brain Families gave no reason for refusal in about Author: dead Not mentioned half of the cases Chapman 112 considered for Religious and cultural views et al. donation Characteristics of cases: Prevent mutilation of the body (1995) Patients’ wishes prior to death Control group: Not mentioned Refusal by one individual in a family group Study type: N/A Retrospective Baseline Measurements: study Study period: Not mentioned Apr 1991 to Mar 1992

Setting: 9 hospitals, NSW, Sydney Additional comments: Reference: Chapman, JR, Hibberd, AD, McCosker, C, Thompson, JF, Ross, W, Mahony, J, Byth, P, Macdonald, GJ Obtaining consent for organ donation in nine NSW metropolitan hospitals. Anaesthesia & Intensive Care 1995; 23: 81-87.

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Title: The timing factor in the consent process. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aims were to examine who was N/A Table: Consent by request or role 526 203 referrals /Exclusion (study initiating the topic of donation and the 127 cases group): consent, view ‘decoupling’ and its Requestor Requests Consent Consent Author: were suitable effects, and identify when families obtained rate (%) Niles for family Not mentioned were being asked for donation and the Physician 82 40 49 et al. (1996) approach for effects of timing on the consent rate. Nurse 23 12 52 consent Characteristics of OPO 5 2 40 Study type: cases: A data collection questionnaire, coordinator Retrospective Control group: developed by OPO coordinators, was Family 17 17 study N/A Not mentioned completed by one of three OPO initiated coordinators receiving referral. Total 127 71 56 Study period: Baseline Jan 1994 to Measurements: Nov 1995 NA Physicians asked 82 families and obtained 40 consents. Setting: Dayton Nurses made 23 requests and acquired 12 Regional consents. Office, Ohio OPO coordinators requested donation on 5 occasions and obtained 2 consents.

The family initiated discussion in 17 of the consents acquired. Additional comments: Reference: Niles, PA, Mattice, BJ The timing factor in the consent process. Journal of Transplant Coordination 1996; 6: 84-87.

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Title: Decoupling: What is it and does it really help increase consent to organ donation? Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study was to N/A There was a greater likelihood of the family 97 11 560 medical /Exclusion(study define what decoupling was and donating if the patient was younger (p≤ records of deceased group): provide data from a large national 0.05) Author: study that examines a variety of Siminoff Control group: Not mentioned factors to determine the value of The family has stronger pro-donation et al. N/A decoupling. attitudes (p ≤ 0.0001), and (2002) Characteristics of Study period: cases: In-depth interviews were conducted The family felt they had enough information Study type: Jan 1994 to Dec with family members, healthcare about the patient’s wishes (p ≤ 0.0001). Retrospective 1999 Not mentioned professional and OPO staff involved in study the process. Donation was also associated with Setting: Baseline agreement between the healthcare 9 trauma hospitals, Measurements: professional and the family about the initial Southwest Not mentioned reaction regarding donation (p ≤ 0.01) Pennsylvania and Northeast Ohio. An increased likelihood of donation was also associated with equating the patient’s death with brain death compared with family respondents who considered the patient dead only when the heart stopped beating. Additional comments: Reference: Siminoff, LA, Lawrence, RH, Zhang, A Decoupling: what is it and does it really help increase consent to organ donation? Progress in Transplantation 2002; 12: 52- 60.

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Title: Donor families’ experience of organ donation. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion The purpose of this study was to N/A 86% (n=36) felt they were given 97 108 consenting /Exclusion(study group): survey the donor families in the state enough information to prepare families of Queensland, to evaluate their themselves for the fact that their loved Author: 12 not contactable 12 paediatric donors experience of the donation process. one would not survive. Douglass 44 indicated under the age of 12 et al. willingness to years were excluded 90% were able to understand the (1995) participate explanation of brain death that was 42 returned Characteristics of cases: provided to them. Study type: questionnaires Retrospective Not mentioned 86% found that the request regarding study Control group: organ donation was made in a N/A Baseline Measurements: sensitive manner. Not mentioned Study period: 83% were given the opportunity to ask Jan 1991 to Dec questions. 1992 86% felt they were given enough time Setting: to discuss the issue of organ donation Queensland, and to make their decision. Australia 81% felt that the timing of the request for organ donation (at completion of brain death tests) was appropriate.

93% felt they were given enough time to say their final goodbye.

60% indicated that they were offered some form of follow-up from either Social Worker or Transplant Coordinator and 83% found the contact helpful. Additional comments: Reference: Douglass, GE, Daly, M Donor families' experience of organ donation. Anaesthesia and Intensive Care 1995; 23: 96-98.

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Title: Parental consent for pediatric cadaveric organ donation. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose was to N/A Opinions and general knowledge about organ 506 152 households /Exclusion(study improve understandings transplantation 97-donors group): of why parents do or do Author: 55-non donors not consent to donate Non donors were somewhat less likely to believe that doctors Weiss et al. 78 completed Entry criteria for their child’s organs. who determine brain death were not participants in the (1997) questionnaires parents were: donation process (64% vs. 87%, p = 0.056). 64-donors 1. Their child has It was a survey by mailed Study type: 14- non donors been declared questionnaire and no Parents’ perceptions about the hospital experience Retrospective dead by whole family was contacted study Control group: brain criteria until at least 9 months Parents agreeing with Donors Non- p-value (survey) N/A 2. Their child after the child’s death. statement (n-64) Donors ranged in age No. (%) (n-14) Study period: from birth to 18 No. (%) Jan 1990 to Jun years I was not happy with my 17(27) 4 (29) 1.000 1992 3. They spoke child’s medical treatment English or I knew enough about 35 (55) 8 (62) 0.764 Setting: Spanish. what was going on with USA my child Characteristics of I felt supported by the 48 (76) 11 (79) 1.000 cases: hospital staff Not mentioned The hospital did not let 10 (16) 3 (21) 0.697 me spend enough time Baseline with my child. Measurements: Not applicable. There was no statistical difference between donors and non- donor parents in their perception about in-hospital experience surrounding their child’s critical illness and death.

The consent process

Non-donor parents were significantly more dissatisfied with the consent process (50% vs. 8%, p = 0.002). One parent said: ‘the doctor was so angry when I said no that I wondered if he or the hospital were going to make money

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from my son’s organs-like he had already sold them or something.’

Non-donor parents were also significantly less likely to feel they had been given enough information to make an informed decision about organ donation (57% vs. 87%, p = 0.023)

Non-donor parents were somewhat less likely to feel the time they were asked about organ donation was the best time (50% vs. 77%, p = 0.057).

Parents’ reasons for not donating their child’s organs

The most prevalent reasons mentioned by non-donor parents were:

My child had already been through enough (79%) I don’t like the idea of my child being cut for organs (71%) Organ donation was too upsetting at the time to think about (62%).

Parents’ reasons for donating their child’s organs

Donor parents reasons for donating were:

Donating organs helps other children live (95%) If I or someone in my family needed a transplant, I would want someone to donate organs for us (90%) Donating organs is the right thing to do (89%) Donating organs makes me feel like part of my child is still living (70%)

Key results from telephone interview

Half of the undecided non-donor parents chose not to donate due to their perception of insensitivity, either on the part of the hospital staff involved in their child’s care or during the request for organ donation. The following statements were made:

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‘I am generally in favor of organ donation…but the staff changed my mind because of the way it was handled…all the doctor wanted to do was unplug my child’ ‘If we had been handled differently, we probably would have said yes…but the doctor was so cruel.’

‘My child had wanted to donate. We talked about it as a family. It was definitely the way it was handled…they were circling over his body like a bunch of vultures.’

On the other side, the undecided donor parents specifically stated that their interactions with hospital personnel or the transplant coordinator positively influenced their decision o donate. Additional comments:

Reference: Weiss, AH, Fortinsky, RH, Laughlin, J, Lo, B, Adler, NE, Mudge, C, Dimand, RJ Parental consent for pediatric cadaveric organ donation. Transplantation Proceedings 1997; 29: 1896-901.

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Title: Pediatric organ transplantation and the Hispanic population: approaching families and obtaining their consent. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion To evaluate whether the odds of being approached for N/A 100% of H/C families (n=22) 288 250 deaths /Exclusion(study and obtaining consent to pediatric organ donation were approached for organ 63 declared group): differed among Hispanic/Caucasian (H/C) and non- donation Author: brain dead Hispanic/Caucasian (NH/C). 85% of NH/C families (n=41) Pietz Not mentioned were approached (p ≤ 0.08) et . al Control H/C refers to people who have a Spanish background, (2004) group: Characteristics of including people from Central and South America and 55% of NH/C consented to N/A cases: people from Spanish-speaking Caribbean countries. organ donation Study type: Not mentioned 27% of H/C families consented Retrospective Study period: NH/C refers to all those who are not African American, (p ≤ 0.03) study 1990 to 1999 Baseline Asian, Native American Indian, Middle Easterners, Measurements: pacific Islanders, or those included in the description of The estimated odds ratio that Setting: Not applicable. H/C above. an H/C family would consent 3 hospitals in was 0.31 compared to NH/C San Antonia, family (p ≤ 0.033) Texas Additional comments: Reference: Pietz, CA, Mayes, T, Naclerio, A, Taylor, R Pediatric organ transplantation and the hispanic population: approaching families and obtaining their consent. Transplantation Proceedings 2004; 36: 1237-40.

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Title: Parental Willingness To Donate the Organs of a Child. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The purpose of this study was to survey a N/A Table 1: Reasons for refusal of child organ 776 group: /Exclusion(study randomly selected sample of adults in a donation 585 group): large southeastern state to determine their Author: individuals attitudes toward organ donation for Agreed with reason Frauman Not mentioned themselves, a spouse, if they were n-143 et al. (1987) Control married, or a child, if they were parents. In n (%) group: Characteristics of the case of unwillingness to consent to Idea bothers 106 (74) Study type: N/A cases: organ donation of a child, the reasons me Retrospective were explored. Body 87 (61) study Study Mean age- 47 mutilation (survey) period: years(19-91) Might 46 (32) 1986 81%-white interfere with 18%-minority survival Setting: groups (blacks and Don’t 46 (32) University native Americans) understand of North the procedure Carolina Baseline Against 33 (23) Measurements: religion Not mentioned The reason most frequently agreed with was "the whole idea bothers me" (74%) followed by the reason "body mutilation" (62%).

A significantly (p < 0.05) higher percentage of minorities (36%) as compared to whites (17%) gave as their reason for refusal that organ donation was against their religious beliefs and that they were concerned that organ donation might interfere with survival (57% of minorities as compared with 33% of whites).

Significant relationships were found with income (p < 0.0001), gender (p < 0.04), and education (p < 0.002). Additional comments:

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 177 of 202 Reference: Frauman, AC, Miles, MS Parental willingness to donate the organs of a child. Anna Journal 1987; 14: 401-4.

Title: The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study was N/A The decision-making process with regard to organ 959 29 Families of /Exclusion(study to explore the decision-making donation children group): process of parents who were Author: 22 consented invited to donate the organs Even though the final decision was made at a spousal level, Bellali et (11 consents Not mentioned and tissues of their brain dead in most cases, the extended family played a significant role in al. and 11 refusals) child. the decision-making process. (2006) 9 declined Characteristics of participation cases: Participants were interviewed. Whenever parents held an open, honest and trustful Study type: relationship with the ICU personnel, they were more likely to Qualitative Control group: Not mentioned accept the finality of the child's condition and consent to the study N/A donation. Baseline Study period: Measurements: Factors affecting the decision toward organ donation 1995 to 2002. Not mentioned Personal factors Setting: Pediatric Perceived finality of the child’s death- When a parent intensive care accepted the irreversibility of death he or she tended to units (PICUs), consent and vice versa. Greece. The meaning attributed, to the act of donation- Several donor parents were prompted by altruistic motives and their desire to help another child live and/or relieve the suffering of other parents

Child’s presumed desire- Even though organ donation was not discussed in any family prior to the child's death, they argued that donation reflected the child's desire to help other people and/or was in agreement with his or her personality.

Fear of mutilation or disrespect towards the child’s body.

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Conditions of organ request

The large majority of donor and non-donor parents described in detail how physicians had informed them about the non- reversibility of the child's condition and explained brain death to them. A few hours later the same physicians approached one or both parents and, in a private office, presented them with the option to donate the child's organs.

Interestingly, before this formal request, quite often a member of the personnel approached a relative or family friend and informally suggested the possibility of organ donation, which was subsequently communicated to parents through their kin. This 'indirect approach' was welcomed by parents and seemed to have a positive effect upon their decision to donate the child's organs.

In fact, the time to reflect allowed them to feel more prepared to consider the physician's request for organ donation.

The relationship that parents developed with the ICU staff was important to their decision. When they were informed about the child's condition and shared an honest and trustful relationship, they were more likely to consent.

Some parents declined organ donation mostly because of the unsatisfactory relationship they held with health professionals, and the inappropriate manner by which they were informed and pressured to decide.

Prior knowledge and experience with regard to donation and illness

Parents were likely to decline if they had no prior knowledge about organ donation, and/or wanted to know personally the recipient. When a child's brain death occurred after a long illness, parents were less likely to consent to organ donation because they felt they did not want to subject their child to 'a new

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 179 of 202 ordeal', even though they were aware that he or she was not alive.

Interpersonal factors

A critical variable affecting the final decision was the process by which the decision was made among people who were involved in the process. All donor parents decided by consensus with their spouse to donate the organs. Additional comments: Reference: Bellali, T, Papadatou, D The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Social Science and Medicine 2007; 64: 439-50.

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Title: Empirically based recommendations to support parents facing the dilemma of pediatric cadaver organ donation. Study type No. of Prevalence/ Patient characteristics Methods Reference Results people incidence standard ID: Study N/A Inclusion /Exclusion(study The aim of the study was to N/A The pre-donation period 138 group: group): describe the challenges donor and 22 families non-donor parents encounter Personal challenges Author: The principal inclusion criterion before, during, and after the organ Bellali et Control was that the child met the donation decision, and to identify Personal challenges comprised the parent's al. group: medical criteria of suitability for parents' needs and expectations ambivalence towards donation, which was (2007) N/A donation at the time of death from health care professionals. affected by one's struggle to understand, from any cause (accidental or assimilate, and accept the child's brain death. Study Study non-accidental). Parents were classified in two Both donor and non-donor parents had great type: period: groups: difficulty to accept the finality of the child's death. Qualitative 1995 to Characteristics of cases: study 2002. Group A (donor parents)- 11 Those who were ultimately unable to cognitively Not mentioned parents who consented to organ and emotionally accept the irreversibility of the Setting: donation, and child's condition, declined organ donation, since Pediatric Baseline Measurements: they hoped for a miracle until the very last intensive Not mentioned Group B (non-donor parents) 11 moment. care units parents who refused both organ (PICUs), and tissue donation. Another major difficulty was parents' reluctance Greece. to assume the responsibility to decide over somebody else's organs.

Deciding on whether to donate all or few of the organs was another challenge for both donor and non-donor parents.

The fear of body mutilation or disfigurement along with fantasies about a traumatic appear- ance following organ removal caused increased distress to some donor parents. Before they were able to decide, they requested detailed information and reassurance that the child's body would be respected by health care professionals during organ retrieval.

Parents who lacked knowledge on the issue of

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 181 of 202 organ donation or who were unaware of the church's position on the subject, experienced considerable difficulties throughout the decision making process.

Conditions of organ request

Parents, who felt that their hospitalised child was inappropriately cared for, declined organ donation.

Moreover, when the PICU staff did not facilitate parents' presence at the child's bedside, they experienced increased distress and were reluctant to accept the donation request.

Increased distress was also experienced by parents when staff members did not take the time to provide information about the child's condition, to discuss the odds of survival, and explain the concept of brain death.

The insensitive manner by which some parents were approached with the organ donation request, the limited information they received, and the pressure that was exercised upon them to reach a decision, contributed to their refusal.

Interpersonal challenges

The large majority of non-donor parents attributed their refusal to donate the child's organs to spousal disagreement, spousal unavailability (due to physical or mental condition), or to their reluctance to inform their mate about the option of organ donation.

The post-donation period

Many donor parents reported challenges after

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 182 of 202 consenting to organ donation because they felt at a loss, unsupported, and with no guidance. No one ever told them if they had to stay at the hospital during organ retrieval, whether they would see their child after surgery, and how to handle burial procedures.

Some parents reported that everything hap- pened so fast, that they did not have the opportunity or option to see their child and share their farewells following organ retrieval. This caused increased distress throughout the course of their bereavement.

Moreover, several donor parents were disappointed by the lack of information about the transplantation outcomes, the identity of the recipient, and the possibility of making contact with him or her.

Donor parents in particular, expressed resentment and anger at health care professionals who never expressed concern about their well-being during the period following the child's death. They felt that their act was not socially recognized, that they were quickly forgotten, and few even believed that they had been exploited. Additional comments: Reference: Bellali, T, Papazoglou, I, Papadatou, D Empirically based recommendations to support parents facing the dilemma of paediatric cadaver organ donation. Intensive & Critical Care Nursing 2007; 23: 216-25.

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Title: Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study was to N/A MEANING ATTRIBUTED TO THE ACT OF 174 22 families /Exclusion(study investigate the grieving process of parents ORGAN DONATION group): who were faced with the dilemma of Author: Control donating organs and tissues of their The majority of donor parents believed that the Bellali group: Not mentioned underage brain dead child, and to explore donation eased their grief, but for different et al. N/A the impact of their decision on their grief reasons. (2007) Characteristics of process. Study period: cases: Some felt relieved because they had helped Study type: 1995 to 2002. Parents were classified in two groups: another human being to live, whereas others were Qualitative Not mentioned content that their child remained "alive" through the study Setting: Group A (donor parents) - 11 parents who organ recipient. Pediatric Baseline consented to organ donation, and intensive care Measurements: The meaning they attributed to such "aliveness" units (PICUs), Not mentioned Group B (non-donor parents) - 11 parents affected their grief in positive or negative ways. Greece. who refused both organ and tissue dona- Parents who referred to the child's aliveness or tion. continued existence in symbolic terms were able to grieve over their loss.

Parents who lacked information about the transplantation outcomes experienced an unsettling and stress inducing effect throughout their grief. Some desperately sought information about the recipients' health condition in order to confirm the worthiness of the donation act. Additional comments: Reference: Bellali, T, Papadatou, D Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Death Studies 2006; 30: 883-917.

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Title: Emotional considerations and attending involvement ameliorates organ donation in brain dead pediatric trauma victims. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The purpose of this study was to N/A Pediatric surgeons had a 17 of 22 (77%) success 20 group: /Exclusion(study ascertain a strategy for maximizing rate in obtaining consent for donation, whereas 43 deaths group): parental consent for organ donation in transplant surgeon had a 1 of 1, neurosurgeons a 1 Author: 33 suitable traumatically injured children suffering of 3, adult trauma surgeons a 1 of 6, and pediatric Vane for Not mentioned from brain death. intensivists a 0 of 1 success rate. et al. donation (2001) Characteristics of Control cases: Study type: group: Retrospective N/A Age of donors- study 1month to 18 years Study 27 boys period: 6 girls Jan 1993 to Aug Baseline 1999 Measurements: Not mentioned Setting: USA Additional comments: Reference: Vane, DW, Sartorelli, KH, Reese, J Emotional considerations and attending involvement ameliorates organ donation in brain dead pediatric trauma victims. Journal of Trauma-Injury Infection & Critical Care 2001; 51: 329-31.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 185 of 202 Review Question 3: When is the optimal time for approaching the families, relatives and legal guardians of potential DBD and DCD donors for consent? Title: The timing factor in the consent process. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aims were to examine who was initiating the topic of N/A Before group (n- 526 203 referrals /Exclusion(study donation and the consent, view ‘decoupling’ and its effects, 52) 127 cases were group): and identify when families were being asked for donation and Author: suitable for family the effects of timing on the consent rate. 32 (62%) families Niles approach for Not mentioned gave consent for et al. (1996) consent A data collection questionnaire, developed by OPO donation. Characteristics of coordinators, was completed by one of three OPO coordinators Study type: Control group: cases: receiving referral. Same group (n- Retrospective N/A 12) study Not mentioned Families who were approached for donation were divided in to Study period: 3 subcategories: 3 (25%) families Jan 1994 to Nov Baseline gave consent for 1995 Measurements: 1. Those who were approached for donation before death donation. NA had occurred (‘before’-n- 52). Setting: After group (n- Dayton Regional 2. Those who were asked for donation at the same time they 63) Office, Ohio were being told of the death (‘same’-n-12). 36 (57%) families 3. Those families who were asked for donation after they had gave consent for been told of the death (‘after’-n- 63). donation. Additional comments: Reference: Niles, PA, Mattice, BJ The timing factor in the consent process. Journal of Transplant Coordination 1996; 6: 84-87.

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Title: Emotional considerations and attending involvement ameliorates organ donation in brain dead pediatric trauma victims. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The purpose of this study was to N/A When time to initiation of brain death protocol was 20 group: /Exclusion(study ascertain a strategy for maximizing examined, success was obtained when a mean 43 deaths group): parental consent for organ donation in delay of 15.5 hours was respected vs. a mean Author: 33 suitable traumatically injured children suffering delay of 7.0 hours when donation was requested Vane for Not mentioned from brain death. but denied (p = 0.03) et al. donation (2001) Characteristics of Control cases: Study type: group: Retrospective N/A Age of donors- study 1month to 18 years Study 27 boys period: 6 girls Jan 1993 to Aug Baseline 1999 Measurements: Not mentioned Setting: USA Additional comments: Reference: Vane, DW, Sartorelli, KH, Reese, J Emotional considerations and attending involvement ameliorates organ donation in brain dead pediatric trauma victims. Journal of Trauma-Injury Infection & Critical Care 2001; 51: 329-31.

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Title: Decoupling: What is it and does it really help increase consent to organ donation? Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study was to define N/A Families were most commonly 97 11 560 medical /Exclusion(study what decoupling was and provide data from asked about organ donation records of deceased group): a large national study that examines a concurrent with their loved one’s Author: variety of factors to determine the value of death (40.9%) and had donation Siminoff Control group: Not mentioned decoupling. rates of 51.2% et al. N/A (2002) Characteristics of In-depth interviews were conducted with Followed by before death (39.3%) Study period: cases: family members, healthcare professional with donation rates of 63% Study type: Jan 1994 to Dec 1999 and OPO staff involved in the process. Retrospective Not mentioned Followed by after death with study Setting: donation rates of 56.6% 9 trauma hospitals, Baseline Southwest Measurements: Pennsylvania and Not mentioned Northeast Ohio. Additional comments: Reference: Siminoff, LA, Lawrence, RH, Zhang, A Decoupling: what is it and does it really help increase consent to organ donation? Progress in Transplantation 2002; 12: 52-60.

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Title: Increasing the availability of cadaveric organs for transplantation maximizing the consent rate. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The purpose of this study was to N/A If the request for donation was made following 97 group: /Exclusion(study analyse the variables to determine notification of death as opposed to before or 212 BSD group): what, if any, factor (timing) affected simultaneously with notification of death, the family was Author: patient’s the consent rate and might be more likely to grant consent for donation. This trend Cutler families Not mentioned effectively managed to increase appeared to hold true regardless of who made the et al. donation rates. request for donation. (1993) Control Characteristics of group: cases: Study type: N/A Retrospective Not mentioned study Study period: Baseline 1990 to Measurements: 1991 Not mentioned

Setting: USA Additional comments: Reference: Cutler, JA, David, SD, Kress, CJ, Stocks, LM, Lewino, DM, Fellows, GL, Messer, SS, Zavala, EY, Halasz, NA Increasing the availability of cadaveric organs for transplantation maximizing the consent rate. Transplantation 1993; 56: 225-28.

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Title: A qualitative examination of the needs of families faced with the option of organ donation. Study type No. of people Prevalence/ Patient characteristics Methods Reference Results incidence standard ID: Study group: N/A Inclusion /Exclusion(study The objective was to examine donor and non- N/A Timing of approach 234 98 potential group): donor family members’ perceived needs for participants support while in the hospital intensive care Families in the non-donor group Author: 50 donor family Eligible legal next of kin setting and to gain an in-depth understanding of felt they had not been adequately Jacoby et al 48 non-donor who consented or refused specific support considerations on the basis of a prepared for the request for organ (2005) family donation of their loved theoretical framework. donation. 33/50 refused one’s organs. Study type: in donor group The research questions were: They also felt they had not been Qualitative 42/48 refused Characteristics of cases: clearly informed that their loved study in non-donor Age range- 31-65 years 1. How do donor and non-donor families one was brain dead before being (interviews) group (mean-43 yrs) describe and interpret the communication and approached about organ donation. 11 finally behaviors of people they interacted with during participated Baseline Measurements: the donation process and how do these In contrast, donor families depicted from donor Not mentioned descriptions differ? the timing of the approach ‘as group good as could have been’ and no 5 from non 2. What can we learn from families’ accounts of one described problems with the donor group their perceived need for support in relation to manner of the approach by staff their donation decision and how do the 2 groups members. Control group: differ in this respect? N/A Being given the time and 3. What are the implications for care and opportunity to spend time with their Study period: interventions that would effectively address loved one and to ‘say goodbye’ July 1998 to families’ perceived needs for support? was a recurring theme among Dec. 2000 donor families.

Setting: 3 sites in New York Additional comments: Reference: Jacoby, LH, Breitkopf, CR, Pease, EA A qualitative examination of the needs of families faced with the option of organ donation. DCCN - Dimensions of Critical Care Nursing 2005; 24: 183-89.

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Title: Donor and non-donor families' accounts of communication and relations with healthcare professionals. Study type No. of Prevalence/ Patient Methods Reference Results people incidence characteristics standard ID: Study N/A Inclusion The wider research objective was N/A The impact of time 290 group: /Exclusion(study to conduct a sociological Donor group): investigation into the experiences, An important factor aiding understanding of the brain Author: families-19 attitudes, and belief systems of death diagnosis was said to be the availability of time. Haddow (2004) Non-donor Not mentioned donor and non-donor families. families-4 For e.g.: A donor spouse claimed she was unaware her Study type: Characteristics of Semi structured interviews over a husband was dead when asked for her lack of objection Qualitative Control cases: 2-year period was conducted in. to remove organs: "[I thought], 'Yes, I'll sign the kidney retrospective group: Not mentioned The interviews were conducted at donation form and if anything happens, if he dies, they study N/A a time and place that suited the can have his kidneys.' I didn't realise that it set the whole Baseline respondents. process in motion." Study Measurements: period: Not mentioned Organ request Not mentioned Most respondents said that a consultant had made the request following the results of the brain-death tests, Setting: generally with some degree of privacy, although 1 donor Scotland family complained it was made in a public place.

Also, because transplant coordinators did not wear a uniform, donor families mentioned it was easier to speak to them. Additional comments: A warning regarding the bias nature of the sample toward donor families might be noted and that "saturation" was not reached with the non-donor families. Comparisons are therefore made with other research conducted in the area. Equally, given the scope of this paper, the discussion does not address why donor and non-donor families refused or agreed to donation. Reference: Haddow, G Donor and nondonor families' accounts of communication and relations with healthcare professionals. Progress in Transplantation 2004; 14: 41-48.

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Title: Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The aim was to explore how relatives N/A Accepting or declining request 199 20 relatives /Exclusion(study and physicians understood cases (donors and group): where organ donation had been Donation Author: non-donors) requested and what factors were Sanner 25 physicians Not mentioned salient for the decision on donation. In 4 cases, relatives at first impulsively declined the et al. request, initially reacting with uneasiness and felt too (2007) Control group: Characteristics of Relatives were mostly interviewed in exhausted to make a decision. However, the N/A cases: their homes, but in some cases in our physicians gave time for discussion, gently pointed Study type: offices. Physicians were either out the benefits of a donation, and introduced the Qualitative Study period: Not mentioned interviewed by telephone or in their perspective of recipients. study Not offices. The initial uneasiness subsided when relatives had mentioned Baseline time to start cognitive operations and consider rational Measurements: An open interview method was chosen and altruistic ideas in their deliberations. They were Setting: Not mentioned to allow informants to speak freely also encouraged to talk with other close kin. Sweden about their experiences, although predetermined issues were also covered. Additional comments: Reference: Sanner, MA Two perspectives on organ donation: experiences of potential donor families and intensive care physicians of the same event. Journal of Critical Care 2007; 22: 296-304.

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Title: The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study was N/A Factors affecting the decision toward organ donation 959 29 Families of /Exclusion(study to explore the decision-making children group): process of parents who were Personal factors Author: 22 consented invited to donate the organs Bellali et (11 consents Not mentioned and tissues of their brain dead Perceived finality of the child’s death- When a parent al. and 11 refusals) child. accepted the irreversibility of death he or she tended to (2006) 9 declined Characteristics of consent and vice versa. participation cases: Participants were interviewed. Study type: Conditions of organ request Qualitative Control group: Not mentioned study N/A The large majority of donor and non-donor parents described Baseline in detail how physicians had informed them about the non- Study period: Measurements: reversibility of the child's condition and explained brain death 1995 to 2002. Not mentioned to them. A few hours later the same physicians approached one or both parents and, in a private office, presented them Setting: with the option to donate the child's organs. Pediatric intensive care Interestingly, before this formal request, quite often a member units (PICUs), of the personnel approached a relative or family friend and Greece. informally suggested the possibility of organ donation, which was subsequently communicated to parents through their kin. This 'indirect approach' was welcomed by parents and seemed to have a positive effect upon their decision to donate the child's organs.

In fact, the time to reflect allowed them to feel more prepared to consider the physician's request for organ donation. Additional comments: Reference: Bellali, T, Papadatou, D The decision-making process of parents regarding organ donation of their brain dead child: A Greek study. Social Science and Medicine 2007; 64: 439-50.

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Title: Empirically based recommendations to support parents facing the dilemma of pediatric cadaver organ donation. Study type No. of Prevalence/ Patient characteristics Methods Reference Results people incidence standard ID: Study group: N/A Inclusion /Exclusion(study The aim of the study was to describe N/A The pre-donation period 138 22 families group): the challenges donor and non-donor parents encounter before, during, and Personal challenges Author: Control The principal inclusion criterion after the organ donation decision, and Bellali et group: was that the child met the to identify parents' needs and Personal challenges comprised the al. N/A medical criteria of suitability for expectations from health care parent's ambivalence towards donation, (2007) donation at the time of death professionals. which was affected by one's struggle to Study from any cause (accidental or understand, assimilate, and accept the Study type: period: non-accidental). Parents were classified in two groups: child's brain death. Both donor and non- Qualitative 1995 to donor parents had great difficulty to accept study 2002. Characteristics of cases: Group A (donor parents)- 11 parents the finality of the child's death. who consented to organ donation, Setting: Not mentioned and Conditions of organ request Pediatric intensive Baseline Measurements: Group B (non-donor parents) 11 The insensitive manner by which some care units Not mentioned parents who refused both organ and parents were approached with the organ (PICUs), tissue donation. donation request, the limited information Greece. they received, and the pressure that was exercised upon them to reach a decision, contributed to their refusal.

Interpersonal challenges

The large majority of non-donor parents attributed their refusal to donate the child's organs to spousal disagreement, spousal unavailability (due to physical or mental condition), or to their reluctance to inform their mate about the option of organ donation.

The post-donation period

Some parents reported that everything happened so fast, that they did not have

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 194 of 202 the opportunity or option to see their child and share their farewells following organ retrieval. This caused increased distress throughout the course of their bereavement. Additional comments: Reference: Bellali, T, Papazoglou, I, Papadatou, D Empirically based recommendations to support parents facing the dilemma of paediatric cadaver organ donation. Intensive & Critical Care Nursing 2007; 23: 216-25.

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Title: Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Study type No. of people Prevalence/ Patient Methods Reference Results incidence characteristics standard ID: Study group: N/A Inclusion The purpose of this study was to N/A Meaning attributed to the act of organ donation 174 22 families /Exclusion(study investigate the grieving process of parents group): who were faced with the dilemma of The majority of donor parents believed that the Author: Control donating organs and tissues of their donation eased their grief, but for different Bellali group: Not mentioned underage brain dead child, and to explore reasons. et al. N/A the impact of their decision on their grief (2007) Characteristics of process. Some felt relieved because they had helped Study period: cases: another human being to live, whereas others were Study type: 1995 to 2002. Parents were classified in two groups: content that their child remained "alive" through the Qualitative Not mentioned organ recipient. study Setting: Group A (donor parents)- 11 parents who Pediatric Baseline consented to organ donation, and The meaning they attributed to such "aliveness" intensive care Measurements: affected their grief in positive or negative ways. units (PICUs), Not mentioned Group B (non-donor parents) 11 parents Parents who referred to the child's aliveness or Greece. who refused both organ and tissue dona- continued existence in symbolic terms were able to tion. grieve over their loss.

Parents who lacked information about the transplantation outcomes experienced an unsettling and stress inducing effect throughout their grief. Some desperately sought information about the recipients' health condition in order to confirm the worthiness of the donation act. Additional comments: Reference: Bellali, T, Papadatou, D Parental grief following the brain death of a child: does consent or refusal to organ donation affect their grief? Death Studies 2006; 30: 883-917.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 196 of 202 Review Question 4: How should the care pathway of deceased organ donation be coordinated to improve potential donors giving consent? Title: Texas non-donor-hospital project: a program to increase organ donation in community and rural hospitals Level of Patient Population/ Selection/Inclusion criteria Intervention Comparison Follow- Outcome and Results Evidence Characteristics up ID: 226 Setting: Non-donor hospitals: Placement of in- Pre- 24 Results were 20 non-donor >100 beds, house coordinators introduction months . 1991- 1995- Increase Study type: practice hospitals in US regional or community centres, Establishment of 3 7 (%) Observational routine notification Date: 1991-3 had ICUs, operating rooms, Organ Free telephone 22 121 450 Authors: staff neurologists and an referrals service Shafer et al anaesthesiologist Hospitals (1998) In-service training making community based providing 13 19 46 services to local residents Date: 1995-7 organ referrals Organ 2.67 10 275 donors Hospitals with at 3 5 67 least 1 donor Organs 8.01 33 312 recovered

Additional comments: Limited number of data points. Complex intervention, so not able to attribute changes to single factor. Introduction into non-donor hospitals, so not able to estimated impact in hospitals with existing donor programmes. Reference: T. J. Shafer, R. Durand, M. J. Hueneke, W. S. Wolff, K. D. Davis, R. N. Ehrle, C. T. Van Buren, J. P. Orlowski, D. H. Reyes, R. T. Gruenenfelder, and C. K. White. Texas non-donor-hospital project: a program to increase organ donation in community and rural hospitals. Journal of Transplant Coordination 8 (3):146-152, 1998.

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 197 of 202 Title: Increasing organ recovery from level I trauma centres: The in-house coordinator intervention Level of Patient Population/ Characteristics Selection/Inclusion criteria Intervention Comparison Follow-up Outcome and Results Evidence ID: 284 Results in the abstract are described as follows: ‘Comparison data were obtained on 83 level I trauma centers nationally. Data from 1999 to 2000 were compared with data from 2001 to 2002. Results- Despite demographic differences, the 8 centers with in-house coordinators had higher consent rates (60% vs 53%) and conversion rates (55% vs 45%) than Study type: centers without them. Conversion of potential to actual donors was 22% higher in centers with in-house coordinators than in centers without them. Donation Observational rates were affected by donor age, ethnicity, previous family discussion of donation, the family's initial reaction to the request (favorable, unfavorable, undecided), amount of time family spent with the in-house coordinator, presence of the in-house coordinator during explanation of brain death, whether the Authors: request was made at the same time as the brain-death explanation, and, in cases where donation was mentioned to the family before the formal request, who Shafer et al first mentioned donation to the family.’ (2004) However, methods were reported poorly and results not clear. Overall, results were Centres without in-house coordinators Centres with in-house coordinators (n=8) (n=6) Consent rate (%) 60 53 Conversion rate (%) 55 48

Additional comments: Poorly reported study, with information from other published studies included? Also not possible to relate results in the abstract to those presented in the paper. Reference: T. J. Shafer, R. N. Ehrle, K. D. Davis, R. E. Durand, S. M. Holtzman, C. T. Van Buren, N. J. Crafts, and P. J. Decker. Increasing organ recovery from level I trauma centres: The in-house coordinator intervention. Progress in Transplantation 14 (3):250-263, 2004.

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Title: Cadaveric organ donor recruitment at Los Angeles county hospital; improvement after formation of a structured clinical educational and administrative service. Study type No. of Patient Methods Results people characteristi cs ID: Study Inclusion The aims Table 1: Comparison of organ donation between 62 group: /Exclusion were to the 2 time periods Not (study examine who Author: mention group): was initiating Parame Statist 199 199 % p- Roth ed the topic of ter ic 6-98 9-01 chan value et al. Not donation and ge (2003) Control mentioned the effect of a Patient 3 year 256 373 +46% 0.04 group: new approach referrals total 95 Study N/A Characterist had on organ for Mean 85 ± 124 type: ics of cases: donation. organ per 9 ± 30 Observatio Study donatio year ± nal study period: Not Key n SD 1996 to mentioned components Suitable 3 year 155 190 +23% 0.10 2001 of the new donor total 46 Baseline approach/prog Mean 52 ± 63 ± Setting: Measureme ram me were: per 1 10 USA nts: year ± NA 1. A full time SD in-house Actual 3 year 46 77 +67% 0.04 transplant donor total 95 nurse Mean 15 ± 26 ± coordinat per 2 5 or from year ± the local SD organ Actual 3 year 157 267 +70% 0.04 procurem organs total 95 ent donated Mean 52 ± 89 ± organizati per 7 24 on (OPO) year ± was SD stationed

at LAC- It is noteworthy that total hospital admissions UC. declined slightly during the time period from phase I Functions to phase II. of the

coordinat In a comparison of Phase I and Phase II, there was or a 46% increase in referrals to the OPO, a mean of included 86 vs. 124 per year (p = 0.0495). interactin

g and There was a significant increase in the mean educating number of actual donors (15/year vs. 26/year, hospital p = 0.0495) from phase I to phase II. personnel

, This difference was also noted in the mean number coroner’s of organs donated (52/year vs. 89/year, represent p = 0.0495). atives,

and The significant increases noted are to a greater approachi level of awareness and coordination. ng the families of potential donors. 2. The combined service strictly enforced this donation

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 199 of 202 approach within the hospital. 3. Trauma and critical care services took the role of identifying , stabilising and managing potential organ donors. 4. A resuscitati on protocol was develope d to provide standardi zed care for trauma patients with intracrani al injuries in the pre- admission ward and in the ICU. 5. Biweekly multidisci plinary donor managem ent conferenc es were instituted to review the managem ent of every patient who suffered brain death to determine any deficienci es in administr ative, clinical, or legal procedure

Organ donation for transplantation: NICE clinical guideline 135 – appendices Page 200 of 202 that resulted in a failure of donation. Correctiv e actions were taken dependin g on the deficienci es identified.

Two phases were compared.

Phase I-1996 to 1998 where no institutional programme was in place Phase II- 1999 to 2001- after implementatio n of the new programme. Additional comments: Reference: Roth, BJ, Sher, L, Murray, JA, Belzberg, H, Mateo, R, Heeran, A, Romero, J, Mone, T, Chan, L, Selby, R Cadaveric organ donor recruitment at Los Angeles County Hospital: improvement after formation of a structured clinical, educational and administrative service. Clinical Transplantation 2003; 17: Suppl-7.

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Title: Improving organ donation in Central Saudi Arabia. Study type No. of Patient Methods Results people characteristics ID: Study Inclusion 2 in-house coordinators From Jan 2003 to Sept 53 group: /Exclusion were employed in order to 2003(no in-house Not (study group): facilitate the logistics of the coordinators existed), only Author: mentioned organ donation pathway. 10 patients became actual Al-Sebayel Not mentioned Their work was supervised donors which equates to et al. (2004) Control by a physician forming a 11% yield from total group: Characteristics donor action team, which number reported to the Study type: N/A of cases: helps to coordinate the Saudi Center for Organ Observational effort in organ donation at Transplantation. study Study Not mentioned all stages. period: While from Oct 2003 until Jan 2003 to Baseline Data were gathered end of Dec 2003, 6 patients Dec 2003 Measurements: between Oct 2003 to Dec became actual donors NA 2003 (after employing 2 in- which equates to 32% yield Setting: house coordinators) and from total number reported 3 hospitals these were compared to to the Saudi Center for in Riyadh, similar data collected from Organ Transplantation. Saudi Jan 2003 until Sept 2003 Arabia (no in-house coordinators existed). Additional comments: Reference: Al-Sebayel, MI, Al-Enazi, AM, Al-Sofayan, MS, Al-Saghier, MI, Khalaf, HA, Kabbani, MA, Nafae, OM, Khuroo, SS Improving organ donation in Central Saudi Arabia. Saudi Medical Journal 2004; 25: 1366-68.

Review question 5:

What key skills and competencies are important for healthcare professionals to improve the structures and processes for identifying potential DBD and DCD; to improve structures and processes for obtaining consent; and to effectively coordinate the care pathway from identification to obtaining consent?

As noted above, evidence from other questions was used to inform recommendations on skills and competencies needed. There are therefore no evidence tables for this question.

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